METABolic Deterioration in HTX Determines Outcomes

NCT07372820 | Recruiting

• 1 other identifier: METAB-HTX
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Transplantation

Keywords

cardiac metabolism; Systemic Metabolism; cardiac function; heart transplant; heart failure; Type 2 diabetes

Outcome Measures

Primary Outcomes (8)

• diastolic and systolic left ventricular function

  in cardiac MRI or echocardiography

  Baseline, 1 year, and 2 years after heart transplantation

• CAV diagnosis

  coronary angiography, intravascular imaging and intravascular physiology measuraments

  Baseline, 1 year, and up to 24 months

• Allograft rejection will be evaluated by endomyocardial biopsy

  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.

  1 year and 5 years after heart transplantation

• Worsening of kidney function

  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.

  Baseline, 1 year, and 2 years after heart transplantation

• Infection requiring heath care professional interventions

  clinical events, labs (CRP) , outpatient contact, hospitalisation.

  Baseline, 1 year, and 2 years after heart transplantation

• Diagnosis of malignencies

  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.

  Baseline, 1 year, and 2 years after heart transplantation

• Worsening of metabolic derangements

  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.

  Baseline, 1 year, and 2 years after heart transplantation

• Liver deterioration

  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.

  Baseline, 1 year, and 2 years after heart transplantation

Secondary Outcomes (3)

• 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

Study Arms (1)

Adult advanced heart failure patients listed for HTx

Patients with advanced heat failure (AHF) and listed for heart transplantation (HTx)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients on the heart transplant waiting list, as well as post-heart transplantation

You may qualify if:

• Age: ≥ 18 years
• Planned or already conducted heart transplantation
• Informed consent

You may not qualify if:

• Absence of informed consent

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

University-Hospital Düsseldorf Division of Cardiology, Pneumology and Angiology

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples:including circulating citrullinated histone H3 (H3cit)-DNA complexes

MeSH Terms

Conditions

Heart Failure; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Malte Kelm, Prof.

  Clinic of Cardiology, Pneumology and Vascular Medicine at University Hospital Düsseldorf

  STUDY CHAIR

Central Study Contacts

Amin Polzin, Prof.

CONTACT

0211 81 18801; amin.polzin@med.uni-duesseldorf.de

Fabian Voß, Dr. med.

CONTACT

02118118800; fabian.voss@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 28, 2026
• Study Start: July 24, 2025
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): February 1, 2032
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

DE (1)