Status:
RECRUITING
Effect of Antifibrotic Therapy on Regression of Myocardial Fibrosis After Transcatheter Aortic Valve Implantation (TAVI) in Aortic Stenosis Patients With High Fibrotic Burden
Lead Sponsor:
University Medical Center Goettingen
Conditions:
Aortic Stenosis, Severe
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
The aim of the study is to evaluate the effect of antifibrotic therapy on regression of myocardial fibrosis after TAVI in patients with baseline high fibrotic burden. Therefore, patients will be treat...
Eligibility Criteria
Inclusion
- Male, female age ≥ 60
- Diagnosis of severe symptomatic aortic stenosis
- Transcatheter aortic valve implantation (TAVI) scheduled
- Written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
February 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05230901
Start Date
February 23 2022
End Date
March 1 2026
Last Update
June 28 2022
Active Locations (1)
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1
University Medical Center Göttingen
Göttingen, Lower Saxony, Germany, 37075