Effect of anti-fibrotic therapy on regression of myocardial fibrosis after transcatheter aortic valve implantation (TAVI) in aortic stenosis patients with high fibrotic burden (Reduce-MFA-DZHK25)

ID

NCT05230901

Status

Active

DZG

DZHK

Start date

02/23/2022

Parameters

Inclusion criteria
  • Male
  • female age ≥ 60 Diagnosis of severe symptomatic aortic stenosis Transcatheter aortic valve implantation (TAVI) scheduled Written informed consent
Exclusion criteria
  • 1. Pre-existing dilative or ischemic heart disease with EF<35% and guideline indication for spironolactone 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 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