NCT07372820

METABolic Deterioration in HTX Determines Outcomes

METAB-HTX: Prospective, Longitudinal Cohort Study Evaluationg Cardiac and Systemic Metabolism After Heart Transplantation

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 270 (estimated)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

METAB-HTX is a prospective, longitudinal cohort study evaluating cardiac and systemic metabolism in heart transplant recipients.

Detailed description

Bankground: Heart Transplantation (HTS) is the treatment of choice for advanced heart failure, yet long-time survival rates require further improvement. Recent studies highlight obesity, type 2 diabetes, renal dysfunction, and hepatic impairment as key contributors to post-transplant mortality. Furthermore, critical questions persist in understanding the optimal metabolic surveillance post-HTX, the direct association between metabolic dysregulation and cardiac dysfunction, inter-organ interactions linking metabolic decline to hepatic/renal impairment and the timing of therapeutic strategies. Therefore: METAB-HTX study aims to address these open questions, hypothesizing that metabolic deterioration post-HTX is associated with impaired cardiac function and survival. Study Design: The study employs advanced multi-modal phenotyping to investigate interactions between cardiac function, metabolic dysregulation, and systemic organ dysfunction. Cardiac Phenotyping: * Imaging: Serial echocardiography, cardiac MRI (cMRI), and magnetic resonance spectroscopy (MRS) for myocardial structure, perfusion, and metabolic profiling. * Vascular Evaluation: Coronary angiography to detect macro- and microvascular coronary allograft vasculopathy (CAV). * Rejection Monitoring: Protocol-driven endomyocardial biopsies for histopathological grading. Metabolic phenotyping: * Serial oral glucose tolerance tests, homeostasis model assessment, type 2 diabetes endotyping and muscle biopsies. * Advanced lipid panels, HDL functional assays and plasma membrane lipid fluidity analyses. * MRI/MRS-based quantification of adipose tissue distribution and ectopic fat deposition. Systemic Organ Evaluation: * renal and liver function. Molecular and Multi-Omics Integration: * Myocardial Energy Metabolism, Genomic/Transcriptomic Profiling, Thromoboinflammation and Neoplasia Risk. This innovative study aims to bridge critical gaps in understanding post-transplant metabolic pathophysiology, potentially refining surveillance protocols and guiding targeted therapies to improve long-term survival through precision medicine strategies

Conditions

• Heart Transplantation

Timeline

• Start date: 2025-07-24
• Primary completion: 2030-04-01
• Completion: 2032-02-01
• First posted: 2026-01-28
• Last updated: 2026-01-28

Locations

1 site across 1 country: Germany