Genomics in Heart Transplants

NCT06012162 | Not Yet Recruiting

• 1 other identifier: Genomics in HTx
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

A cross-sectional analysis of 200 heart transplant recipients, combining in-depth phenotyping and risk factor assessment (cardiac MRI, coronary angiogram with OCT, cardiorespiratory exercise tests, exogenic factors like nutrition, smoking, lipid profile) with short-read whole-genome sequencing to elucidate the interplay of established PRS from the literature and exogenic risk factors with respect to HTx outcomes will be carried out. Besides that, a long-read whole-genome sequencing of 100 newly transplanted recipients and their corresponding donors and extend latest bioinformatics methods developed by the study to analyze long-read data will be performed. This will enable a comprehensive and integrated analysis of structural variants, polygenic risk, high-penetrance variant genotypes, immunogenetic (major and minor histocompatibility), and individual lifestyle risk factors in a unique donor-recipient cohort, elucidating the extent of within-cohort variability and cross-correlations between the considered potential risk factors and an exploratory analysis of the utility of genetic risk scores in light of the study results will be carried out.

Conditions

Heart Transplantation

Keywords

heart transplantation; long-read genomics; risk stratification; myocardial ischemia

Outcome Measures

Primary Outcomes (1)

• rate of Clinically significant ischemia

  defined by cardiac allograft vasculopathy (CAV) grade \>1 \& cardiac magnetic resonance imaging (cMRI)

  5 years

Secondary Outcomes (6)

• cardiovascular death

  5 years

• myocardial infarction

  5 years

• Hospitalisation (w/o allograft rejection)

  5 years

• Cardiac allograft vasculopathy (macrocirculatory)

  5 years

• number of coronary microvascular dysfunction

  5 years

Eligibility Criteria

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

Study Population

Patients undergoing heart transplantation

You may qualify if:

• Patients \> 18 years old undergoing heart transplantation in our centre

You may not qualify if:

• \< 18 years
• incapable of giving consent

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Collection of blood samples through clinical routine

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Malte Kelm, Prof.

  Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf

  STUDY CHAIR

Central Study Contacts

Daniel Oehler, MD

CONTACT

+492118118800; Daniel.oehler@med.uni-duesseldorf.de

Lisa Dannenberg, MD

CONTACT

+49211811800; lisa.dannenberg@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: April 4, 2023
• First Posted: August 25, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 25, 2023

Record last verified: 2023-08

Locations

DE (1)