METABolic Deterioration in HTX Determines Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Transplantation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
METAB-HTX: Prospective, Longitudinal Cohort Study Evaluationg Cardiac and Systemic Metabolism After Heart Transplantation
Overview
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
Primary outcome measures
- diastolic and systolic left ventricular function [Time frame: Baseline, 1 year, and 2 years after heart transplantation]
- CAV diagnosis [Time frame: Baseline, 1 year, and up to 24 months]
- Allograft rejection will be evaluated by endomyocardial biopsy [Time frame: 1 year and 5 years after heart transplantation]
- Worsening of kidney function [Time frame: Baseline, 1 year, and 2 years after heart transplantation]
- Infection requiring heath care professional interventions [Time frame: Baseline, 1 year, and 2 years after heart transplantation]
- Diagnosis of malignencies [Time frame: Baseline, 1 year, and 2 years after heart transplantation]
- Worsening of metabolic derangements [Time frame: Baseline, 1 year, and 2 years after heart transplantation]
- Liver deterioration [Time frame: Baseline, 1 year, and 2 years after heart transplantation]
Secondary outcome measures (3)
- Hospitalisation due to heart transplant events [Time frame: up to 5 years (follow-up in clinical routine)]
- Cardiovascular mortality and all-cause mortality [Time frame: up to 5 years (follow-up in clinical routine)]
- Re-transplantation or ventricular assist device implantation [Time frame: Through study completion, up to 5 years after heart transplantation]
Eligibility criteria
Inclusion criteria
- Age: ≥ 18 years
- Planned or already conducted heart transplantation
- Informed consent
Exclusion criteria
- Absence of informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University-Hospital Düsseldorf Division of Cardiology, Pneumology and Angiology — Düsseldorf
Identifiers
NCT: NCT07372820 · METAB-HTX