METABolic Deterioration in HTX Determines Outcomes

Condition(s) studied

Study summary

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

Eligibility

Primary outcome measure(s)

• diastolic and systolic left ventricular function — Baseline, 1 year, and 2 years after heart transplantation
  in cardiac MRI or echocardiography
• CAV diagnosis — Baseline, 1 year, and up to 24 months
  coronary angiography, intravascular imaging and intravascular physiology measuraments
• Allograft rejection will be evaluated by endomyocardial biopsy — 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 — 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 — Baseline, 1 year, and 2 years after heart transplantation
  clinical events, labs (CRP) , outpatient contact, hospitalisation.
• Diagnosis of malignencies — 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 — 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 — 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.

Trial sites (1)

More Heinrich-Heine University, Duesseldorf trials in Germany

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