METABolic Deterioration in HTX Determines Outcomes
ConditionHeart Transplantation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeinrich-Heine University, Duesseldorf
About this trial
METAB-HTX is a prospective, longitudinal cohort study evaluating cardiac and systemic metabolism in heart transplant recipients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: ≥ 18 years
Planned or already conducted heart transplantation
Informed consent
Disqualifiers
Absence of informed consent
Trial population
Patients on the heart transplant waiting list, as well as post-heart transplantation
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
270 Participants
are grouped into 1 trial groupGroup A: Adult advanced heart failure patients listed for HTx
Trial outcomes
Primary outcomes
1
diastolic and systolic left ventricular function
in cardiac MRI or echocardiography
Time frame
Baseline, 1 year, and 2 years after heart transplantation2
CAV diagnosis
coronary angiography, intravascular imaging and intravascular physiology measuraments
Time frame
Baseline, 1 year, and up to 24 months3
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.
Time frame
1 year and 5 years after heart transplantation4
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.
Time frame
Baseline, 1 year, and 2 years after heart transplantationSecondary outcomes
1
Hospitalisation due to heart transplant events
Number of hospitalisations due to heart transplant-related events after study inclusion
Time frame
up to 5 years (follow-up in clinical routine)2
Cardiovascular mortality and all-cause mortality
Survival and clinical outcomes after study index visit (inclusion)
Time frame
up to 5 years (follow-up in clinical routine)3
Re-transplantation or ventricular assist device implantation
Incidence of re-transplantation or ventricular assist device implantation during follow-up.
Time frame
Through study completion, up to 5 years after heart transplantationSponsors and contacts
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Source ClinicalTrials.gov