Heart TransplantationMETAB-HTXNCT07372820
METABolic Deterioration in HTX Determines Outcomes
An observational study of Heart Transplantation, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
METAB-HTX is a prospective, longitudinal cohort study evaluating cardiac and systemic metabolism in heart transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplantation
- How many people
- 270 participants
- Where
- 1 siteGermany
- Study dates
- 24 Jul 2025to 1 Feb 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on the heart transplant waiting list, as well as post-heart transplantation
Who may be able to join
- Age: ≥ 18 years
- Planned or already conducted heart transplantation
- Informed consent
Who cannot join
- Absence of informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University-Hospital Düsseldorf Division of Cardiology, Pneumology and Angiology
Düsseldorf, North Rhine-Westphalia, 40225
Daniel Scheiber, MD, +49211811800, daniel.scheiber@med.uni-duesseldorf.de
Amin Polzin, Prof., +4902118118801, amin.polzin@med.uni-duesseldorf.de
About this study
Official title: METAB-HTX: Prospective, Longitudinal Cohort Study Evaluationg Cardiac and Systemic Metabolism After Heart Transplantation
METAB-HTX is a prospective, longitudinal cohort study evaluating cardiac and systemic metabolism in heart transplant recipients.
Read the 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
- Conditions
- Heart Transplantation
- Keywords
- cardiac metabolism, Systemic Metabolism, cardiac function, heart transplant, heart failure, Type 2 diabetes
- Medical subject headings
- Heart Failure, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult advanced heart failure patients listed for HTx | Patients with advanced heat failure (AHF) and listed for heart transplantation (HTx) |
What is being measured
The primary outcome is the main question the study is designed to answer.
diastolic and systolic left ventricular function
in cardiac MRI or echocardiography
Measured: Baseline, 1 year, and 2 years after heart transplantation
CAV diagnosis
coronary angiography, intravascular imaging and intravascular physiology measuraments
Measured: 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.
Measured: 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.
Measured: Baseline, 1 year, and 2 years after heart transplantation
Infection requiring heath care professional interventions
clinical events, labs (CRP) , outpatient contact, hospitalisation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 year, and 2 years after heart transplantation
Secondary outcomes (3)
Hospitalisation due to heart transplant events
Number of hospitalisations due to heart transplant-related events after study inclusion
Measured: up to 5 years (follow-up in clinical routine)
Cardiovascular mortality and all-cause mortality
Survival and clinical outcomes after study index visit (inclusion)
Measured: up to 5 years (follow-up in clinical routine)
Re-transplantation or ventricular assist device implantation
Incidence of re-transplantation or ventricular assist device implantation during follow-up.
Measured: Through study completion, up to 5 years after heart transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start24 Jul 2025
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malte Kelm, Prof., Study chair, Clinic of Cardiology, Pneumology and Vascular Medicine at University Hospital Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372820
- Sponsor's protocol ID
- METAB-HTX
- Acronym
- METAB-HTX
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- METAB-HTX: Prospective, Longitudinal Cohort Study Evaluationg Cardiac and Systemic Metabolism After Heart Transplantation
- ClinicalTrials.gov ID
- NCT07372820
- Acronym / sponsor ID
- METAB-HTX / METAB-HTX
- Conditions
- Heart Transplantation
- Keywords
- cardiac metabolism, Systemic Metabolism, cardiac function, heart transplant, heart failure, Type 2 diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Feb 2032 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult advanced heart failure patients listed for HTx | – | –Patients with advanced heat failure (AHF) and listed for heart transplantation (HTx) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on the heart transplant waiting list, as well as post-heart transplantation
Key inclusion criteria (3 listed)
- Age: ≥ 18 years
- Planned or already conducted heart transplantation
- Informed consent
Key exclusion criteria (1 listed)
- Absence of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Malte Kelm, Prof. study chair
Clinic of Cardiology, Pneumology and Vascular Medicine at University Hospital Düsseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplantation, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amin Polzin, Prof. (0211 81 18801, amin.polzin@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diastolic and systolic left ventricular function (time frame: Baseline, 1 year, and 2 years after heart transplantation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026; AzTrials last refreshed its copy on 1 Nov 2026.