Effect of antifibrotic therapy on regression of myocardial fibrosis after transcatheter aortic valve implantation (TAVI) in aortic stenosis patients with high fibrotic burde

Phase 1

• Conditions: aortic stenosis patients with high fibrotic burden; MedDRA version: 20.1Level: PTClassification code: 10002906Term: Aortic stenosis Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2024-510869-42-00
• Lead Sponsor: niversitaetsmedizin Goettingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-09
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Male, female age = 60, Diagnosis of severe symptomatic aortic stenosis, Transcatheter aortic valve implantation therapy (TAVI) scheduled, Written informed consent

Exclusion Criteria

Pre-existing dilative or ischemic heart disease with EF<35% and guideline indication for spironolactone, Contraindications for Spironolactone (anuria, acute renal failure, serum creatinine > 1.8 mg/dl, hyperkalemia, pregnancy), Contraindications for Dihydralazine (known allergy or hypersensitivity, systemic lupus erythematodes, adrenocortical disorders), Known active malignant disease with life expectancy < 1 year, Women with child-bearing potential, Simultaneous participation (including a waiting period of 4 weeks) in other interventional clinical trials, Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial, Person who is in a relationship of dependence/employment with the sponsor or the investigator, Known planned operations or catheter-based interventions (e.g. PCI, transcatheter edge-to-edge mitral or tricuspid valve repair) during 3 months after study inclusion; the performance of e.g. PCI immediately before study enrolment and before TAVI is possible, Patient on current medication with spironolactone, eplerenone, or dihydralazine, Presence of coexistent myocardial pathology such as cardiac amyloidosis, hypertrophic cardiomyopathy, or myocarditis, Presence of coexistent severe aortic regurgitation or severe mitral stenosis, Previous surgical valve replacement or repair, Pacemaker or ICD implanted, Renal impairment (serum creatinine > 1,8 mg/dl and/ or GFR < 30 ml/min/1,73 m² BSA), Significant hypotension (blood pressure < 90 mm Hg systolic and/or < 50 mm Hg diastolic, Serum potassium > 5,1 mmol/l

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified