METAB-HTX: Prospective, Longitudinal Cohort Study Evaluationg Cardiac and Systemic Metabolism After Heart Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 270
- Locations
- 1
- Primary Endpoint
- diastolic and systolic left ventricular function
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: ≥ 18 years
- •Planned or already conducted heart transplantation
- •Informed consent
Exclusion Criteria
- •Absence of informed consent
Arms & Interventions
Adult advanced heart failure patients listed for HTx
Patients with advanced heat failure (AHF) and listed for heart transplantation (HTx)
Outcomes
Primary Outcomes
diastolic and systolic left ventricular function
Time Frame: Baseline, 1 year, and 2 years after heart transplantation
in cardiac MRI or echocardiography
CAV diagnosis
Time Frame: Baseline, 1 year, and up to 24 months
coronary angiography, intravascular imaging and intravascular physiology measuraments
Allograft rejection will be evaluated by endomyocardial biopsy
Time Frame: 1 year and 5 years after heart transplantation
Tissue specimens will be collected from the interventricular septum and analyzed by cardiac transplant pathologists. Myocardial inflammation will be assessed in endomyocardial biopsies using immunohistochemistry followed by quantitative digital image analysis. Inflammatory cell infiltration will be quantified as the number of positive cells per square millimeter (mm²), providing a quantitative measure of myocardial inflammatory burden. In addition, biopsy tissue will be used for exploratory molecular analyses.
Worsening of kidney function
Time Frame: Baseline, 1 year, and 2 years after heart transplantation
Renal function will be assessed using estimated glomerular filtration rate (eGFR) as the primary quantitative measure. eGFR will be calculated from serum creatinine and cystatin C obtained from periodic blood sampling. Additional renal assessments, including duplex sonography, urinary markers, and immunological parameters, will be used for supportive and exploratory analyses.
Infection requiring heath care professional interventions
Time Frame: Baseline, 1 year, and 2 years after heart transplantation
clinical events, labs (CRP) , outpatient contact, hospitalisation.
Diagnosis of malignencies
Time Frame: Baseline, 1 year, and 2 years after heart transplantation
By whole-body CT scans, screening for occult blood within the stool and if indicated gastroscopy and coloscopy. Analysis of epigenetic alterations in leukocytes which are associated with post HTX events like neoplasia.
Worsening of metabolic derangements
Time Frame: Baseline, 1 year, and 2 years after heart transplantation
Changes in glucose and lipid metabolism, insulin resistance, HDL function, and body fat distribution will be assessed using blood tests, oral glucose tolerance, and imaging in selected participants.
Liver deterioration
Time Frame: Baseline, 1 year, and 2 years after heart transplantation
Liver structure and function will be assessed using blood tests (liver enzymes, bilirubin, albumin, INR), imaging (ultrasound, CT, transient elastography), and fibrosis scores (FIB-4) in selected participants.
Secondary Outcomes
- Hospitalisation due to heart transplant events(up to 5 years (follow-up in clinical routine))
- Cardiovascular mortality and all-cause mortality(up to 5 years (follow-up in clinical routine))
- Re-transplantation or ventricular assist device implantation(Through study completion, up to 5 years after heart transplantation)