Metabolic deterioration after heart transplant determines outcomes
METAB-HTX: Prospective, Longitudinal Cohort Study Evaluationg Cardiac and Systemic Metabolism After Heart Transplantation
We'll test whether worsening cardiac and systemic metabolism after a heart transplant predicts heart function and long-term survival in adult transplant recipients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Locations | 1 site (Düsseldorf, North Rhine-Westphalia) |
| Trial ID | NCT07372820 on ClinicalTrials.gov |
What this trial studies
This is a prospective, longitudinal cohort of adult heart transplant recipients using advanced, multi-modal phenotyping to link metabolic changes with cardiac and systemic organ function. Participants undergo serial cardiac imaging (echocardiography, cardiac MRI, and MR spectroscopy), coronary angiography, protocol endomyocardial biopsies, and detailed metabolic testing including oral glucose tolerance tests, insulin-resistance measures, diabetes endotyping, and muscle biopsies. The study tracks changes over time to determine how metabolic deterioration relates to coronary allograft vasculopathy, rejection, renal and hepatic dysfunction, and clinical outcomes. Findings aim to define optimal metabolic surveillance and timing for interventions after transplant.
Who should consider this trial
Good fit: Adults aged 18 or older who have had or are planned to undergo heart transplantation and can provide informed consent are eligible.
Not a fit: People who are not heart transplant recipients or those unable to attend serial imaging/biopsy visits or provide informed consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could identify metabolic markers that predict decline and guide earlier, targeted interventions to improve post-transplant outcomes.
How similar studies have performed: Previous research has linked obesity, diabetes, and renal impairment to worse post-transplant outcomes, but few longitudinal studies combine cardiac metabolic imaging with systemic phenotyping, so this multi-modal approach is partially novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: ≥ 18 years * Planned or already conducted heart transplantation * Informed consent Exclusion Criteria: * Absence of informed consent
Where this trial is running
Düsseldorf, North Rhine-Westphalia
- University-Hospital Düsseldorf Division of Cardiology, Pneumology and Angiology — Düsseldorf, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Study coordinator: Amin Polzin, Prof.
- Email: amin.polzin@med.uni-duesseldorf.de
- Phone: 0211 81 18801
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.