Effect of Antifibrotic Therapy on Regression of Myocardial Fibrosis After Transcatheter Aortic Valve Implantation (TAVI) in Aortic Stenosis Patients With High Fibrotic Burden (Reduce-MFA)

This is an interventional treatment trial for Aortic Stenosis, Severe Read More

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