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Kaspar Broch - One of the best experts on this subject based on the ideXlab platform.
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health related quality of life in Iron deficient heart transplant recipients receiving intravenous Iron Supplement a prespecified secondary endpoint in the Ironic trial
Journal of Heart and Lung Transplantation, 2021Co-Authors: K Brautaset V Englund, K Rolid, Einar Gude, Arne K Andreassen, Lars Gullestad, C M Oestby, Kaspar BrochAbstract:Purpose Health related quality of life (HRQoL) is reduced in heart transplant (HTx) recipients compared to that of healthy individuals. Intravenous Iron Supplement improves quality of life in patients with heart failure and Iron deficiency (ID). The IronIC trial was designed to test if a single dose of ferric derisomaltose, formerly known as Iron isomaltoside, could improve exercise capacity in HTx recipients. HRQoL was a prespecified secondary endpoint. Methods In the IronIC trial we randomized 102 HTx recipients with ID to ferric derisomaltose or placebo. ID was defined as ferritin Results There was no between-group difference in peak oxygen consumption in the IronIC trial. However, HRQoL was improved in the ferric derisomaltose group compared to controls at follow-up. A significant between group difference was found in the EQ-5D index (Figure 1A), the EQ-5D-VAS (Figure 1B), and the SF-36 MCS (Figure 1C). The SF-36 MCS MCID was also significant. The SF-36 PCS (Figure 1D) and the SF-36 PCS MCID were not significantly different between the groups at follow up. Conclusion The prespecified secondary outcome HRQoL was better in the ferric derisomaltose group. These findings suggest a possible approach to improve HRQoL in HTx recipients, and could provide the basis for a trial designed to assess this issue.
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intravenous Iron Supplement for Iron deficiency in cardiac transplant recipients Ironic a randomized clinical trial
Journal of Heart and Lung Transplantation, 2021Co-Authors: C M Ostby, K Rolid, Einar Gude, Arne K Andreassen, Lars Gullestad, Kristine Brautaset V Englund, Kaspar BrochAbstract:AIMS Heart transplant recipients have reduced exercise capacity despite preserved graft function. The IronIC trial was designed to test the hypothesis that intravenous Iron therapy would improve peak oxygen consumption in these patients. METHODS AND RESULTS This randomized, placebo-controlled, double-blind trial was performed at our national center for heart transplantation. One hundred and 2 heart transplant recipients with a serum ferritin 100 g/liter were enrolled ≥1 year after transplantation. A cardiopulmonary exercise test was performed before administration of the study drug and at 6 months follow-up. The primary endpoint was peak oxygen consumption. Key secondary outcomes included Iron status, handgrip strength, quality of life, and safety. Fifty-two patients were randomized to receive ferric derisomaltose 20 mg/kg, and 50 to placebo. The between-group difference in baseline-adjusted peak oxygen consumption was 0.3 ml/kg/min (95% confidence interval -0.9 to 1.4, p = 0.66). In patients with a baseline ferritin <30 µg/liter, peak oxygen consumption was significantly higher in the ferric derisomaltose arm. At 6 months, Iron stores were restored in 86% of the patients receiving ferric derisomaltose vs 20% in patients receiving placebo (p < 0.001). Quality of life was significantly better in patients receiving ferric derisomaltose. Twenty-seven adverse events occurred in the intravenous Iron group vs 30 in the placebo group (p = 0.39). CONCLUSION Intravenous Iron treatment did not improve peak oxygen consumption in heart transplant recipients with ferritin <100 µg/liter or 100 to 300 µg/liter in combination with transferrin saturation <20%. TRIAL REGISTRATION NUMBER http//www.clinicaltrials.gov identifier NCT03662789.
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intravenous Iron Supplement for Iron deficiency in cardiac transplant recipients Ironic a randomized double blind controlled trial
Journal of Heart and Lung Transplantation, 2020Co-Authors: K Brautaset V Englund, C M Ostby, T Vartdal, K Rolid, Einar Gude, Arne K Andreassen, Lars Gullestad, Kaspar BrochAbstract:Summary of Objectives Heart transplant recipients have reduced exercise capacity despite preserved graft function. Numerous mechanisms may contribute to this impaired exercise tolerance, one of which may be Iron deficiency (ID). Among our heart transplant survivors, 48 % have ID. The IronIC trial (NCT03662789) was designed to test the hypothesis that intravenous (i.v.) Iron therapy will improve exercise capacity assessed by peak oxygen consumption. Methods 102 stable, cardiac transplant recipients with ID, defined as serum ferritin Endpoints The primary objective is to assess baseline-adjusted peak oxygen consumption, six months after one single dose of Iron isomaltoside. Secondary objectives are to assess the impact of treatment on Iron stores, muscle strength, cognitive function, quality of life, safety and tolerability. This study will give insight to whether heart transplant recipients with ID can benefit from intravenous Iron Supplement. Results will be ready for presentation at the 2020 ISHLT conference.
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intravenous Iron Supplement for Iron deficiency in cardiac transplant recipients Ironic rationale and design of a randomized controlled trial
Journal of Heart and Lung Transplantation, 2019Co-Authors: K V Brautaset, C M Ostby, T Vartdal, K Rolid, Einar Gude, Arne K Andreassen, Lars Gullestad, Kaspar BrochAbstract:Purpose Heart transplant recipients have reduced exercise capacity, despite preserved graft function. Numerous mechanisms may contribute to this impaired exercise tolerance, one of which may be Iron deficiency (ID). Among our heart transplant survivors, 48 % have ID defined as serum ferritin Methods The IronIC trial is a randomized, controlled trial designed to test the efficacy and safety of a single bolus of Iron isomaltoside in adult, stable heart transplant recipients with ID. We aim to randomize 100 patients in a 1:1 fashion to receive i.v. Iron isomaltoside 20 mg/ kg body weight, or NaCl, in a double-blind manner. The trial is powered to detect a 1.5 ml/kg/min between-group difference in the change in peak oxygen consumption. Secondary objectives are to assess the impact of treatment on Iron stores, hand grip strength, body composition, cognitive function, quality of life, and safety and tolerability. All participants must provide written, informed consent. Exclusion criteria include hemoglobin Results All regulatory approvals have been obtained. Recruitment started April 2018 and is expected to end April 2019, with last follow-up October 2019. So far, there have been no serious adverse events. Demographics for the first 41 patients are presented in the Table. Conclusion The IronIC trial is an ongoing, randomized, controlled, double blind study designed to assess the efficacy and safety of a single, i.v. bolus of Iron in heart transplant recipients with ID. We expect results to be available at the end of 2019.
K Rolid - One of the best experts on this subject based on the ideXlab platform.
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health related quality of life in Iron deficient heart transplant recipients receiving intravenous Iron Supplement a prespecified secondary endpoint in the Ironic trial
Journal of Heart and Lung Transplantation, 2021Co-Authors: K Brautaset V Englund, K Rolid, Einar Gude, Arne K Andreassen, Lars Gullestad, C M Oestby, Kaspar BrochAbstract:Purpose Health related quality of life (HRQoL) is reduced in heart transplant (HTx) recipients compared to that of healthy individuals. Intravenous Iron Supplement improves quality of life in patients with heart failure and Iron deficiency (ID). The IronIC trial was designed to test if a single dose of ferric derisomaltose, formerly known as Iron isomaltoside, could improve exercise capacity in HTx recipients. HRQoL was a prespecified secondary endpoint. Methods In the IronIC trial we randomized 102 HTx recipients with ID to ferric derisomaltose or placebo. ID was defined as ferritin Results There was no between-group difference in peak oxygen consumption in the IronIC trial. However, HRQoL was improved in the ferric derisomaltose group compared to controls at follow-up. A significant between group difference was found in the EQ-5D index (Figure 1A), the EQ-5D-VAS (Figure 1B), and the SF-36 MCS (Figure 1C). The SF-36 MCS MCID was also significant. The SF-36 PCS (Figure 1D) and the SF-36 PCS MCID were not significantly different between the groups at follow up. Conclusion The prespecified secondary outcome HRQoL was better in the ferric derisomaltose group. These findings suggest a possible approach to improve HRQoL in HTx recipients, and could provide the basis for a trial designed to assess this issue.
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intravenous Iron Supplement for Iron deficiency in cardiac transplant recipients Ironic a randomized clinical trial
Journal of Heart and Lung Transplantation, 2021Co-Authors: C M Ostby, K Rolid, Einar Gude, Arne K Andreassen, Lars Gullestad, Kristine Brautaset V Englund, Kaspar BrochAbstract:AIMS Heart transplant recipients have reduced exercise capacity despite preserved graft function. The IronIC trial was designed to test the hypothesis that intravenous Iron therapy would improve peak oxygen consumption in these patients. METHODS AND RESULTS This randomized, placebo-controlled, double-blind trial was performed at our national center for heart transplantation. One hundred and 2 heart transplant recipients with a serum ferritin 100 g/liter were enrolled ≥1 year after transplantation. A cardiopulmonary exercise test was performed before administration of the study drug and at 6 months follow-up. The primary endpoint was peak oxygen consumption. Key secondary outcomes included Iron status, handgrip strength, quality of life, and safety. Fifty-two patients were randomized to receive ferric derisomaltose 20 mg/kg, and 50 to placebo. The between-group difference in baseline-adjusted peak oxygen consumption was 0.3 ml/kg/min (95% confidence interval -0.9 to 1.4, p = 0.66). In patients with a baseline ferritin <30 µg/liter, peak oxygen consumption was significantly higher in the ferric derisomaltose arm. At 6 months, Iron stores were restored in 86% of the patients receiving ferric derisomaltose vs 20% in patients receiving placebo (p < 0.001). Quality of life was significantly better in patients receiving ferric derisomaltose. Twenty-seven adverse events occurred in the intravenous Iron group vs 30 in the placebo group (p = 0.39). CONCLUSION Intravenous Iron treatment did not improve peak oxygen consumption in heart transplant recipients with ferritin <100 µg/liter or 100 to 300 µg/liter in combination with transferrin saturation <20%. TRIAL REGISTRATION NUMBER http//www.clinicaltrials.gov identifier NCT03662789.
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intravenous Iron Supplement for Iron deficiency in cardiac transplant recipients Ironic a randomized double blind controlled trial
Journal of Heart and Lung Transplantation, 2020Co-Authors: K Brautaset V Englund, C M Ostby, T Vartdal, K Rolid, Einar Gude, Arne K Andreassen, Lars Gullestad, Kaspar BrochAbstract:Summary of Objectives Heart transplant recipients have reduced exercise capacity despite preserved graft function. Numerous mechanisms may contribute to this impaired exercise tolerance, one of which may be Iron deficiency (ID). Among our heart transplant survivors, 48 % have ID. The IronIC trial (NCT03662789) was designed to test the hypothesis that intravenous (i.v.) Iron therapy will improve exercise capacity assessed by peak oxygen consumption. Methods 102 stable, cardiac transplant recipients with ID, defined as serum ferritin Endpoints The primary objective is to assess baseline-adjusted peak oxygen consumption, six months after one single dose of Iron isomaltoside. Secondary objectives are to assess the impact of treatment on Iron stores, muscle strength, cognitive function, quality of life, safety and tolerability. This study will give insight to whether heart transplant recipients with ID can benefit from intravenous Iron Supplement. Results will be ready for presentation at the 2020 ISHLT conference.
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intravenous Iron Supplement for Iron deficiency in cardiac transplant recipients Ironic rationale and design of a randomized controlled trial
Journal of Heart and Lung Transplantation, 2019Co-Authors: K V Brautaset, C M Ostby, T Vartdal, K Rolid, Einar Gude, Arne K Andreassen, Lars Gullestad, Kaspar BrochAbstract:Purpose Heart transplant recipients have reduced exercise capacity, despite preserved graft function. Numerous mechanisms may contribute to this impaired exercise tolerance, one of which may be Iron deficiency (ID). Among our heart transplant survivors, 48 % have ID defined as serum ferritin Methods The IronIC trial is a randomized, controlled trial designed to test the efficacy and safety of a single bolus of Iron isomaltoside in adult, stable heart transplant recipients with ID. We aim to randomize 100 patients in a 1:1 fashion to receive i.v. Iron isomaltoside 20 mg/ kg body weight, or NaCl, in a double-blind manner. The trial is powered to detect a 1.5 ml/kg/min between-group difference in the change in peak oxygen consumption. Secondary objectives are to assess the impact of treatment on Iron stores, hand grip strength, body composition, cognitive function, quality of life, and safety and tolerability. All participants must provide written, informed consent. Exclusion criteria include hemoglobin Results All regulatory approvals have been obtained. Recruitment started April 2018 and is expected to end April 2019, with last follow-up October 2019. So far, there have been no serious adverse events. Demographics for the first 41 patients are presented in the Table. Conclusion The IronIC trial is an ongoing, randomized, controlled, double blind study designed to assess the efficacy and safety of a single, i.v. bolus of Iron in heart transplant recipients with ID. We expect results to be available at the end of 2019.
Lars Gullestad - One of the best experts on this subject based on the ideXlab platform.
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health related quality of life in Iron deficient heart transplant recipients receiving intravenous Iron Supplement a prespecified secondary endpoint in the Ironic trial
Journal of Heart and Lung Transplantation, 2021Co-Authors: K Brautaset V Englund, K Rolid, Einar Gude, Arne K Andreassen, Lars Gullestad, C M Oestby, Kaspar BrochAbstract:Purpose Health related quality of life (HRQoL) is reduced in heart transplant (HTx) recipients compared to that of healthy individuals. Intravenous Iron Supplement improves quality of life in patients with heart failure and Iron deficiency (ID). The IronIC trial was designed to test if a single dose of ferric derisomaltose, formerly known as Iron isomaltoside, could improve exercise capacity in HTx recipients. HRQoL was a prespecified secondary endpoint. Methods In the IronIC trial we randomized 102 HTx recipients with ID to ferric derisomaltose or placebo. ID was defined as ferritin Results There was no between-group difference in peak oxygen consumption in the IronIC trial. However, HRQoL was improved in the ferric derisomaltose group compared to controls at follow-up. A significant between group difference was found in the EQ-5D index (Figure 1A), the EQ-5D-VAS (Figure 1B), and the SF-36 MCS (Figure 1C). The SF-36 MCS MCID was also significant. The SF-36 PCS (Figure 1D) and the SF-36 PCS MCID were not significantly different between the groups at follow up. Conclusion The prespecified secondary outcome HRQoL was better in the ferric derisomaltose group. These findings suggest a possible approach to improve HRQoL in HTx recipients, and could provide the basis for a trial designed to assess this issue.
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intravenous Iron Supplement for Iron deficiency in cardiac transplant recipients Ironic a randomized clinical trial
Journal of Heart and Lung Transplantation, 2021Co-Authors: C M Ostby, K Rolid, Einar Gude, Arne K Andreassen, Lars Gullestad, Kristine Brautaset V Englund, Kaspar BrochAbstract:AIMS Heart transplant recipients have reduced exercise capacity despite preserved graft function. The IronIC trial was designed to test the hypothesis that intravenous Iron therapy would improve peak oxygen consumption in these patients. METHODS AND RESULTS This randomized, placebo-controlled, double-blind trial was performed at our national center for heart transplantation. One hundred and 2 heart transplant recipients with a serum ferritin 100 g/liter were enrolled ≥1 year after transplantation. A cardiopulmonary exercise test was performed before administration of the study drug and at 6 months follow-up. The primary endpoint was peak oxygen consumption. Key secondary outcomes included Iron status, handgrip strength, quality of life, and safety. Fifty-two patients were randomized to receive ferric derisomaltose 20 mg/kg, and 50 to placebo. The between-group difference in baseline-adjusted peak oxygen consumption was 0.3 ml/kg/min (95% confidence interval -0.9 to 1.4, p = 0.66). In patients with a baseline ferritin <30 µg/liter, peak oxygen consumption was significantly higher in the ferric derisomaltose arm. At 6 months, Iron stores were restored in 86% of the patients receiving ferric derisomaltose vs 20% in patients receiving placebo (p < 0.001). Quality of life was significantly better in patients receiving ferric derisomaltose. Twenty-seven adverse events occurred in the intravenous Iron group vs 30 in the placebo group (p = 0.39). CONCLUSION Intravenous Iron treatment did not improve peak oxygen consumption in heart transplant recipients with ferritin <100 µg/liter or 100 to 300 µg/liter in combination with transferrin saturation <20%. TRIAL REGISTRATION NUMBER http//www.clinicaltrials.gov identifier NCT03662789.
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intravenous Iron Supplement for Iron deficiency in cardiac transplant recipients Ironic a randomized double blind controlled trial
Journal of Heart and Lung Transplantation, 2020Co-Authors: K Brautaset V Englund, C M Ostby, T Vartdal, K Rolid, Einar Gude, Arne K Andreassen, Lars Gullestad, Kaspar BrochAbstract:Summary of Objectives Heart transplant recipients have reduced exercise capacity despite preserved graft function. Numerous mechanisms may contribute to this impaired exercise tolerance, one of which may be Iron deficiency (ID). Among our heart transplant survivors, 48 % have ID. The IronIC trial (NCT03662789) was designed to test the hypothesis that intravenous (i.v.) Iron therapy will improve exercise capacity assessed by peak oxygen consumption. Methods 102 stable, cardiac transplant recipients with ID, defined as serum ferritin Endpoints The primary objective is to assess baseline-adjusted peak oxygen consumption, six months after one single dose of Iron isomaltoside. Secondary objectives are to assess the impact of treatment on Iron stores, muscle strength, cognitive function, quality of life, safety and tolerability. This study will give insight to whether heart transplant recipients with ID can benefit from intravenous Iron Supplement. Results will be ready for presentation at the 2020 ISHLT conference.
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intravenous Iron Supplement for Iron deficiency in cardiac transplant recipients Ironic rationale and design of a randomized controlled trial
Journal of Heart and Lung Transplantation, 2019Co-Authors: K V Brautaset, C M Ostby, T Vartdal, K Rolid, Einar Gude, Arne K Andreassen, Lars Gullestad, Kaspar BrochAbstract:Purpose Heart transplant recipients have reduced exercise capacity, despite preserved graft function. Numerous mechanisms may contribute to this impaired exercise tolerance, one of which may be Iron deficiency (ID). Among our heart transplant survivors, 48 % have ID defined as serum ferritin Methods The IronIC trial is a randomized, controlled trial designed to test the efficacy and safety of a single bolus of Iron isomaltoside in adult, stable heart transplant recipients with ID. We aim to randomize 100 patients in a 1:1 fashion to receive i.v. Iron isomaltoside 20 mg/ kg body weight, or NaCl, in a double-blind manner. The trial is powered to detect a 1.5 ml/kg/min between-group difference in the change in peak oxygen consumption. Secondary objectives are to assess the impact of treatment on Iron stores, hand grip strength, body composition, cognitive function, quality of life, and safety and tolerability. All participants must provide written, informed consent. Exclusion criteria include hemoglobin Results All regulatory approvals have been obtained. Recruitment started April 2018 and is expected to end April 2019, with last follow-up October 2019. So far, there have been no serious adverse events. Demographics for the first 41 patients are presented in the Table. Conclusion The IronIC trial is an ongoing, randomized, controlled, double blind study designed to assess the efficacy and safety of a single, i.v. bolus of Iron in heart transplant recipients with ID. We expect results to be available at the end of 2019.
Arne K Andreassen - One of the best experts on this subject based on the ideXlab platform.
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health related quality of life in Iron deficient heart transplant recipients receiving intravenous Iron Supplement a prespecified secondary endpoint in the Ironic trial
Journal of Heart and Lung Transplantation, 2021Co-Authors: K Brautaset V Englund, K Rolid, Einar Gude, Arne K Andreassen, Lars Gullestad, C M Oestby, Kaspar BrochAbstract:Purpose Health related quality of life (HRQoL) is reduced in heart transplant (HTx) recipients compared to that of healthy individuals. Intravenous Iron Supplement improves quality of life in patients with heart failure and Iron deficiency (ID). The IronIC trial was designed to test if a single dose of ferric derisomaltose, formerly known as Iron isomaltoside, could improve exercise capacity in HTx recipients. HRQoL was a prespecified secondary endpoint. Methods In the IronIC trial we randomized 102 HTx recipients with ID to ferric derisomaltose or placebo. ID was defined as ferritin Results There was no between-group difference in peak oxygen consumption in the IronIC trial. However, HRQoL was improved in the ferric derisomaltose group compared to controls at follow-up. A significant between group difference was found in the EQ-5D index (Figure 1A), the EQ-5D-VAS (Figure 1B), and the SF-36 MCS (Figure 1C). The SF-36 MCS MCID was also significant. The SF-36 PCS (Figure 1D) and the SF-36 PCS MCID were not significantly different between the groups at follow up. Conclusion The prespecified secondary outcome HRQoL was better in the ferric derisomaltose group. These findings suggest a possible approach to improve HRQoL in HTx recipients, and could provide the basis for a trial designed to assess this issue.
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intravenous Iron Supplement for Iron deficiency in cardiac transplant recipients Ironic a randomized clinical trial
Journal of Heart and Lung Transplantation, 2021Co-Authors: C M Ostby, K Rolid, Einar Gude, Arne K Andreassen, Lars Gullestad, Kristine Brautaset V Englund, Kaspar BrochAbstract:AIMS Heart transplant recipients have reduced exercise capacity despite preserved graft function. The IronIC trial was designed to test the hypothesis that intravenous Iron therapy would improve peak oxygen consumption in these patients. METHODS AND RESULTS This randomized, placebo-controlled, double-blind trial was performed at our national center for heart transplantation. One hundred and 2 heart transplant recipients with a serum ferritin 100 g/liter were enrolled ≥1 year after transplantation. A cardiopulmonary exercise test was performed before administration of the study drug and at 6 months follow-up. The primary endpoint was peak oxygen consumption. Key secondary outcomes included Iron status, handgrip strength, quality of life, and safety. Fifty-two patients were randomized to receive ferric derisomaltose 20 mg/kg, and 50 to placebo. The between-group difference in baseline-adjusted peak oxygen consumption was 0.3 ml/kg/min (95% confidence interval -0.9 to 1.4, p = 0.66). In patients with a baseline ferritin <30 µg/liter, peak oxygen consumption was significantly higher in the ferric derisomaltose arm. At 6 months, Iron stores were restored in 86% of the patients receiving ferric derisomaltose vs 20% in patients receiving placebo (p < 0.001). Quality of life was significantly better in patients receiving ferric derisomaltose. Twenty-seven adverse events occurred in the intravenous Iron group vs 30 in the placebo group (p = 0.39). CONCLUSION Intravenous Iron treatment did not improve peak oxygen consumption in heart transplant recipients with ferritin <100 µg/liter or 100 to 300 µg/liter in combination with transferrin saturation <20%. TRIAL REGISTRATION NUMBER http//www.clinicaltrials.gov identifier NCT03662789.
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intravenous Iron Supplement for Iron deficiency in cardiac transplant recipients Ironic a randomized double blind controlled trial
Journal of Heart and Lung Transplantation, 2020Co-Authors: K Brautaset V Englund, C M Ostby, T Vartdal, K Rolid, Einar Gude, Arne K Andreassen, Lars Gullestad, Kaspar BrochAbstract:Summary of Objectives Heart transplant recipients have reduced exercise capacity despite preserved graft function. Numerous mechanisms may contribute to this impaired exercise tolerance, one of which may be Iron deficiency (ID). Among our heart transplant survivors, 48 % have ID. The IronIC trial (NCT03662789) was designed to test the hypothesis that intravenous (i.v.) Iron therapy will improve exercise capacity assessed by peak oxygen consumption. Methods 102 stable, cardiac transplant recipients with ID, defined as serum ferritin Endpoints The primary objective is to assess baseline-adjusted peak oxygen consumption, six months after one single dose of Iron isomaltoside. Secondary objectives are to assess the impact of treatment on Iron stores, muscle strength, cognitive function, quality of life, safety and tolerability. This study will give insight to whether heart transplant recipients with ID can benefit from intravenous Iron Supplement. Results will be ready for presentation at the 2020 ISHLT conference.
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intravenous Iron Supplement for Iron deficiency in cardiac transplant recipients Ironic rationale and design of a randomized controlled trial
Journal of Heart and Lung Transplantation, 2019Co-Authors: K V Brautaset, C M Ostby, T Vartdal, K Rolid, Einar Gude, Arne K Andreassen, Lars Gullestad, Kaspar BrochAbstract:Purpose Heart transplant recipients have reduced exercise capacity, despite preserved graft function. Numerous mechanisms may contribute to this impaired exercise tolerance, one of which may be Iron deficiency (ID). Among our heart transplant survivors, 48 % have ID defined as serum ferritin Methods The IronIC trial is a randomized, controlled trial designed to test the efficacy and safety of a single bolus of Iron isomaltoside in adult, stable heart transplant recipients with ID. We aim to randomize 100 patients in a 1:1 fashion to receive i.v. Iron isomaltoside 20 mg/ kg body weight, or NaCl, in a double-blind manner. The trial is powered to detect a 1.5 ml/kg/min between-group difference in the change in peak oxygen consumption. Secondary objectives are to assess the impact of treatment on Iron stores, hand grip strength, body composition, cognitive function, quality of life, and safety and tolerability. All participants must provide written, informed consent. Exclusion criteria include hemoglobin Results All regulatory approvals have been obtained. Recruitment started April 2018 and is expected to end April 2019, with last follow-up October 2019. So far, there have been no serious adverse events. Demographics for the first 41 patients are presented in the Table. Conclusion The IronIC trial is an ongoing, randomized, controlled, double blind study designed to assess the efficacy and safety of a single, i.v. bolus of Iron in heart transplant recipients with ID. We expect results to be available at the end of 2019.
Einar Gude - One of the best experts on this subject based on the ideXlab platform.
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health related quality of life in Iron deficient heart transplant recipients receiving intravenous Iron Supplement a prespecified secondary endpoint in the Ironic trial
Journal of Heart and Lung Transplantation, 2021Co-Authors: K Brautaset V Englund, K Rolid, Einar Gude, Arne K Andreassen, Lars Gullestad, C M Oestby, Kaspar BrochAbstract:Purpose Health related quality of life (HRQoL) is reduced in heart transplant (HTx) recipients compared to that of healthy individuals. Intravenous Iron Supplement improves quality of life in patients with heart failure and Iron deficiency (ID). The IronIC trial was designed to test if a single dose of ferric derisomaltose, formerly known as Iron isomaltoside, could improve exercise capacity in HTx recipients. HRQoL was a prespecified secondary endpoint. Methods In the IronIC trial we randomized 102 HTx recipients with ID to ferric derisomaltose or placebo. ID was defined as ferritin Results There was no between-group difference in peak oxygen consumption in the IronIC trial. However, HRQoL was improved in the ferric derisomaltose group compared to controls at follow-up. A significant between group difference was found in the EQ-5D index (Figure 1A), the EQ-5D-VAS (Figure 1B), and the SF-36 MCS (Figure 1C). The SF-36 MCS MCID was also significant. The SF-36 PCS (Figure 1D) and the SF-36 PCS MCID were not significantly different between the groups at follow up. Conclusion The prespecified secondary outcome HRQoL was better in the ferric derisomaltose group. These findings suggest a possible approach to improve HRQoL in HTx recipients, and could provide the basis for a trial designed to assess this issue.
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intravenous Iron Supplement for Iron deficiency in cardiac transplant recipients Ironic a randomized clinical trial
Journal of Heart and Lung Transplantation, 2021Co-Authors: C M Ostby, K Rolid, Einar Gude, Arne K Andreassen, Lars Gullestad, Kristine Brautaset V Englund, Kaspar BrochAbstract:AIMS Heart transplant recipients have reduced exercise capacity despite preserved graft function. The IronIC trial was designed to test the hypothesis that intravenous Iron therapy would improve peak oxygen consumption in these patients. METHODS AND RESULTS This randomized, placebo-controlled, double-blind trial was performed at our national center for heart transplantation. One hundred and 2 heart transplant recipients with a serum ferritin 100 g/liter were enrolled ≥1 year after transplantation. A cardiopulmonary exercise test was performed before administration of the study drug and at 6 months follow-up. The primary endpoint was peak oxygen consumption. Key secondary outcomes included Iron status, handgrip strength, quality of life, and safety. Fifty-two patients were randomized to receive ferric derisomaltose 20 mg/kg, and 50 to placebo. The between-group difference in baseline-adjusted peak oxygen consumption was 0.3 ml/kg/min (95% confidence interval -0.9 to 1.4, p = 0.66). In patients with a baseline ferritin <30 µg/liter, peak oxygen consumption was significantly higher in the ferric derisomaltose arm. At 6 months, Iron stores were restored in 86% of the patients receiving ferric derisomaltose vs 20% in patients receiving placebo (p < 0.001). Quality of life was significantly better in patients receiving ferric derisomaltose. Twenty-seven adverse events occurred in the intravenous Iron group vs 30 in the placebo group (p = 0.39). CONCLUSION Intravenous Iron treatment did not improve peak oxygen consumption in heart transplant recipients with ferritin <100 µg/liter or 100 to 300 µg/liter in combination with transferrin saturation <20%. TRIAL REGISTRATION NUMBER http//www.clinicaltrials.gov identifier NCT03662789.
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intravenous Iron Supplement for Iron deficiency in cardiac transplant recipients Ironic a randomized double blind controlled trial
Journal of Heart and Lung Transplantation, 2020Co-Authors: K Brautaset V Englund, C M Ostby, T Vartdal, K Rolid, Einar Gude, Arne K Andreassen, Lars Gullestad, Kaspar BrochAbstract:Summary of Objectives Heart transplant recipients have reduced exercise capacity despite preserved graft function. Numerous mechanisms may contribute to this impaired exercise tolerance, one of which may be Iron deficiency (ID). Among our heart transplant survivors, 48 % have ID. The IronIC trial (NCT03662789) was designed to test the hypothesis that intravenous (i.v.) Iron therapy will improve exercise capacity assessed by peak oxygen consumption. Methods 102 stable, cardiac transplant recipients with ID, defined as serum ferritin Endpoints The primary objective is to assess baseline-adjusted peak oxygen consumption, six months after one single dose of Iron isomaltoside. Secondary objectives are to assess the impact of treatment on Iron stores, muscle strength, cognitive function, quality of life, safety and tolerability. This study will give insight to whether heart transplant recipients with ID can benefit from intravenous Iron Supplement. Results will be ready for presentation at the 2020 ISHLT conference.
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intravenous Iron Supplement for Iron deficiency in cardiac transplant recipients Ironic rationale and design of a randomized controlled trial
Journal of Heart and Lung Transplantation, 2019Co-Authors: K V Brautaset, C M Ostby, T Vartdal, K Rolid, Einar Gude, Arne K Andreassen, Lars Gullestad, Kaspar BrochAbstract:Purpose Heart transplant recipients have reduced exercise capacity, despite preserved graft function. Numerous mechanisms may contribute to this impaired exercise tolerance, one of which may be Iron deficiency (ID). Among our heart transplant survivors, 48 % have ID defined as serum ferritin Methods The IronIC trial is a randomized, controlled trial designed to test the efficacy and safety of a single bolus of Iron isomaltoside in adult, stable heart transplant recipients with ID. We aim to randomize 100 patients in a 1:1 fashion to receive i.v. Iron isomaltoside 20 mg/ kg body weight, or NaCl, in a double-blind manner. The trial is powered to detect a 1.5 ml/kg/min between-group difference in the change in peak oxygen consumption. Secondary objectives are to assess the impact of treatment on Iron stores, hand grip strength, body composition, cognitive function, quality of life, and safety and tolerability. All participants must provide written, informed consent. Exclusion criteria include hemoglobin Results All regulatory approvals have been obtained. Recruitment started April 2018 and is expected to end April 2019, with last follow-up October 2019. So far, there have been no serious adverse events. Demographics for the first 41 patients are presented in the Table. Conclusion The IronIC trial is an ongoing, randomized, controlled, double blind study designed to assess the efficacy and safety of a single, i.v. bolus of Iron in heart transplant recipients with ID. We expect results to be available at the end of 2019.
