dentification of patient-specific molecular pathological mechanisms of reduced left ventricular ejection fraction and myocardial recovery potential in patients with aortic valve stenosis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039629

Enrollment

100

Registered

2026-04-14

Start date

2026-04-15

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reduced systolic left ventricular ejection fraction <50% I35.0

Interventions

Group 1: Prospective observation of patients with severe aortic valve stenosis (AS) and reduced left ventricular ejection fraction (EF <50%) who undergo transcatheter aortic valve implantation (TAVI)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Severe aortic valve stenosis 2) Reduced left ventricular systolic ejection fraction (<50%) 3) Indication for TAVI or AKE in accordance with current guideline recommendations or Heart Team consensus 4) Willingness to voluntarily participate in the study with a signed informed consent form

Exclusion criteria

Exclusion criteria: 1) Known pregnancy at the time of enrollment 2) Life expectancy <1 year due to another non-cardiac condition 3) Prior TAVI or SAVR 4) Known myocarditis, infiltrative disease, or other primary non-valvular cardiomyopathies

Design outcomes

Primary

Measure	Time frame
A composite clinical endpoint consisting of all-cause mortality and rehospitalization due to heart failure. Data collection before intervention, as well as 1 (T1) and 6 (T2) months following the interventional or surgical treatment of aortic valve stenosis. Data collection as part of clinical follow-up using patient records, hospital information systems, and structured follow-up of study participants. Primary translational endpoint for identifying mechanisms causally associated with myocardial recovery („TAVI responders“). Through the analysis of myocardial biopsies at the time of the intervention and the linkage of clinical follow-up data at 1 month (T1) and 6 months (T2). Evaluation is performed using molecular biological analysis of myocardial biopsies, imaging studies to assess myocardial fibrosis, and functional parameters of isolated cardiomyocytes.	—

Measure

Time frame

A composite clinical endpoint consisting of all-cause mortality and rehospitalization due to heart failure. Data collection before intervention, as well as 1 (T1) and 6 (T2) months following the interventional or surgical treatment of aortic valve stenosis. Data collection as part of clinical follow-up using patient records, hospital information systems, and structured follow-up of study participants. Primary translational endpoint for identifying mechanisms causally associated with myocardial recovery („TAVI responders“). Through the analysis of myocardial biopsies at the time of the intervention and the linkage of clinical follow-up data at 1 month (T1) and 6 months (T2). Evaluation is performed using molecular biological analysis of myocardial biopsies, imaging studies to assess myocardial fibrosis, and functional parameters of isolated cardiomyocytes.

—

Secondary

Measure	Time frame
1. Imaging- and biopsy-based secondary endpoints 1.1) Extent and distribution of myocardial fibrosis and changes in follow-up (e.g., via MRI, histology) in subgroups before intervention and at 1 and 6 months 1.2) molecular biological markers (e.g., via single-cell RNA-seq, proteomics, transcriptomics, epigenetics) for both irreversible pathological and reversible remodelling at the time of intervention 1.3) functional parameters from isolated cardiomyocytes (assessed, e.g., via contractility, Ca²? signalling, patch clamp) at the time of intervention 2. Clinical secondary endpoints (pre-intervention, 1 and 6 months post-intervention) 2.1) Symptoms: NYHA class, CCS class 2.2) Quality of life: Kansas City Cardiomyopathy Questionnaire (KCCQ), Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) 2.3) Biomarker changes: NT-proBNP, troponin, creatinine 2.4) echocardiographic parameters: left ventricular ejection fraction, GLS calve orifice area, transvalvular gradients, aortic regurgitation	—

Measure

Time frame

1. Imaging- and biopsy-based secondary endpoints 1.1) Extent and distribution of myocardial fibrosis and changes in follow-up (e.g., via MRI, histology) in subgroups before intervention and at 1 and 6 months 1.2) molecular biological markers (e.g., via single-cell RNA-seq, proteomics, transcriptomics, epigenetics) for both irreversible pathological and reversible remodelling at the time of intervention 1.3) functional parameters from isolated cardiomyocytes (assessed, e.g., via contractility, Ca²? signalling, patch clamp) at the time of intervention 2. Clinical secondary endpoints (pre-intervention, 1 and 6 months post-intervention) 2.1) Symptoms: NYHA class, CCS class 2.2) Quality of life: Kansas City Cardiomyopathy Questionnaire (KCCQ), Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) 2.3) Biomarker changes: NT-proBNP, troponin, creatinine 2.4) echocardiographic parameters: left ventricular ejection fraction, GLS calve orifice area, transvalvular gradients, aortic regurgitation

—

Countries

Germany

Contacts

Public ContactMatthias Renker

Campus Kerckhoff der JLU Gießen, Kerckhoff Klinik GmbH

m.renker@kerckhoff-klinik.de+4960329960

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026