Effect of antifibrotic therapy on heart tissue healing after valve replacement in patients with aortic stenosis
Effect of Antifibrotic Therapy on Regression of Myocardial Fibrosis After Transcatheter Aortic Valve Implantation (TAVI) in Aortic Stenosis Patients With High Fibrotic Burden
This study is testing if adding a medication called dihydralazine to spironolactone can help heart tissue heal better after valve replacement in people with severe aortic stenosis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University Medical Center Goettingen Academic / other |
| Locations | 1 site (Göttingen, Lower Saxony) |
| Trial ID | NCT05230901 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of antifibrotic therapy on the regression of myocardial fibrosis in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). Participants will be treated with either spironolactone alone, spironolactone combined with dihydralazine, or standard care without study medications. The effectiveness of these treatments will be assessed through cardiac magnetic resonance imaging (CMR) before and one year after the procedure. The study aims to determine if the addition of dihydralazine enhances the antifibrotic effects of spironolactone.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 60 and older with severe symptomatic aortic stenosis scheduled for TAVI.
Not a fit: Patients with pre-existing heart diseases, certain coexisting myocardial pathologies, or those currently on specific heart medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart tissue recovery and function in patients with aortic stenosis.
How similar studies have performed: While the approach of using antifibrotic therapy in this context is novel, similar studies have shown promise in other cardiac conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Göttingen, Lower Saxony
- University Medical Center Göttingen — Göttingen, Lower Saxony, Germany (Recruiting)
Study contacts
- Study coordinator: Miriam Puls, Prof.
- Email: dr.m.puls@med.uni-goettingen.de
- Phone: +49 551 3910958
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.