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)

  • STATUS
    Recruiting
  • End date
    Mar 12, 2026
  • participants needed
    300
  • sponsor
    University Medical Center Goettingen
Updated on 12 July 2022

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 treated with Spironolactone in addition to standard of care, Spioronolactone + Dihydralazine in addition to standard of care or according to standard of care alone without any study medication. First, differences between patients in the control arm and patients randomized to anti-fibrotic therapy will be analyzed. The second analysis will determine, whether dihydralazine medication in addition to spironolactone is able to increase a potential antifibrotic effect. Myocardial fibrosis will be assessed by cardiac magnetic resonance imaging (CMR) before TAVI and 1 year after. Quantification of potentially irreversible replacement fibrosis will be carried out by late gadolinium enhancement (LGE), and quantification of the potentially reversible diffuse interstitial fibrosis will be performed by measurement of the extracellular volume fraction (ECV), thereby deriving matrix volume and cell volume.

Details
Condition Aortic Stenosis, Severe
Treatment Standard of Care, Spironolactone 25mg, Dihydralazine
Clinical Study IdentifierNCT05230901
SponsorUniversity Medical Center Goettingen
Last Modified on12 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

\. 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
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