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Comparing non-ischaemic heart preservation (NIHP) with ischaemic static cold storage of donor hearts in adult cardiac transplantation: study protocol for a randomised controlled trial

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Názov: Comparing non-ischaemic heart preservation (NIHP) with ischaemic static cold storage of donor hearts in adult cardiac transplantation: study protocol for a randomised controlled trial
Autori: Pigot, Henry, Steen, Stig, Nilsson, Johan
Prispievatelia: Lund University, Faculty of Medicine, Department of Translational Medicine, Artificial Intelligence and Bioinformatics in Cardiothoracic Sciences (AIBCTS), Lunds universitet, Medicinska fakulteten, Institutionen för translationell medicin, Artificiell intelligens och bioinformatik inom thoraxkirurgisk vetenskap, Originator, Lund University, Faculty of Engineering, LTH, LTH Profile areas, LTH Profile Area: AI and Digitalization, Lunds universitet, Lunds Tekniska Högskola, LTH profilområden, LTH profilområde: AI och digitalisering, Originator, Lund University, Faculty of Engineering, LTH, LTH Profile areas, LTH Profile Area: Engineering Health, Lunds universitet, Lunds Tekniska Högskola, LTH profilområden, LTH profilområde: Teknik för hälsa, Originator, Lund University, Profile areas and other strong research environments, Strategic research areas (SRA), ELLIIT: the Linköping-Lund initiative on IT and mobile communication, Lunds universitet, Profilområden och andra starka forskningsmiljöer, Strategiska forskningsområden (SFO), ELLIIT: the Linköping-Lund initiative on IT and mobile communication, Originator, Lund University, Faculty of Medicine, Department of Clinical Sciences, Lund, Section II, Thoracic Surgery, Heart and Lung transplantation, Lunds universitet, Medicinska fakulteten, Institutionen för kliniska vetenskaper, Lund, Sektion II, Thoraxkirurgi, Hjärt- och lungtransplantation, Originator, Lund University, Faculty of Medicine, Department of Clinical Sciences, Lund, Section II, Thoracic Surgery, Heparin bindning protein in cardiothoracic surgery, Lunds universitet, Medicinska fakulteten, Institutionen för kliniska vetenskaper, Lund, Sektion II, Thoraxkirurgi, Heparinbindande protein inom thoraxkirurgi, Originator, Lund University, Profile areas and other strong research environments, Strategic research areas (SRA), eSSENCE: The e-Science Collaboration, Lunds universitet, Profilområden och andra starka forskningsmiljöer, Strategiska forskningsområden (SFO), eSSENCE: The e-Science Collaboration, Originator
Zdroj: BMJ Open. 15(6):1-7
Predmety: Medical and Health Sciences, Clinical Medicine, Cardiology and Cardiovascular Disease, Medicin och hälsovetenskap, Klinisk medicin, Kardiologi och kardiovaskulära sjukdomar, Surgery, Kirurgi
Popis: Introduction Ischaemia-reperfusion (I/R) injury remains a major challenge in heart transplantation, with mortality risk increasing significantly when allograft ischaemic time exceeds 4 hours. Non-ischaemic heart preservation (NIHP), using continuous hypothermic perfusion, has shown promise in preliminary studies for reducing I/R injury and improving outcomes. This randomised controlled trial aims to compare NIHP with standard static cold storage (SCS) in adult heart transplantation. Methods and analysis The trial is a prospective, open-label, multicentre, single-blinded, randomised controlled trial including 66 adult heart transplant recipients across four Swedish hospitals. Participants will be randomised into 1:1 ratio to NIHP or SCS preservation groups and undergo a 12-month follow-up period. The primary outcome is 1-year survival free from acute cellular rejection or retransplantation. Secondary outcomes include quality of life, I/R injury markers, graft function and adverse events. Substudies will evaluate renal function using MRI and continuously monitor physical activity and heart rhythm via wearable devices. Analysis will follow intention-to-treat principles, with time-to-event analysis using Cox proportional hazard models and Kaplan-Meier estimates. Ethics and dissemination The study has been approved by the Swedish Ethical Review Authority. It will be conducted according to the Declaration of Helsinki and relevant local and international regulations. Results will be published in peer-reviewed journals following Consolidated Standards of Reporting Trials guidelines.
Prístupová URL adresa: https://doi.org/10.1136/bmjopen-2025-100553
Databáza: SwePub
Popis
Abstrakt:Introduction Ischaemia-reperfusion (I/R) injury remains a major challenge in heart transplantation, with mortality risk increasing significantly when allograft ischaemic time exceeds 4 hours. Non-ischaemic heart preservation (NIHP), using continuous hypothermic perfusion, has shown promise in preliminary studies for reducing I/R injury and improving outcomes. This randomised controlled trial aims to compare NIHP with standard static cold storage (SCS) in adult heart transplantation. Methods and analysis The trial is a prospective, open-label, multicentre, single-blinded, randomised controlled trial including 66 adult heart transplant recipients across four Swedish hospitals. Participants will be randomised into 1:1 ratio to NIHP or SCS preservation groups and undergo a 12-month follow-up period. The primary outcome is 1-year survival free from acute cellular rejection or retransplantation. Secondary outcomes include quality of life, I/R injury markers, graft function and adverse events. Substudies will evaluate renal function using MRI and continuously monitor physical activity and heart rhythm via wearable devices. Analysis will follow intention-to-treat principles, with time-to-event analysis using Cox proportional hazard models and Kaplan-Meier estimates. Ethics and dissemination The study has been approved by the Swedish Ethical Review Authority. It will be conducted according to the Declaration of Helsinki and relevant local and international regulations. Results will be published in peer-reviewed journals following Consolidated Standards of Reporting Trials guidelines.
ISSN:20446055
DOI:10.1136/bmjopen-2025-100553