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Effect of antifibrotic therapy on regression of myocardial fibrosis after transcatheter aortic valve implantation (TAVI) in aortic stenosis patients with high fibrotic burden
EU CTIS ID: 2024-510869-42-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male, female age ≥ 60
- Diagnosis of severe symptomatic aortic stenosis
- Transcatheter aortic valve implantation therapy (TAVI) scheduled
- Written informed consent
You likely can't join if
- Pre-existing dilative or ischemic heart disease with EF<35% and guideline indication for spironolactone
- 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
See the full eligibility criteria
- Male, female age ≥ 60
- Diagnosis of severe symptomatic aortic stenosis
- Transcatheter aortic valve implantation therapy (TAVI) scheduled
- Written informed consent
- Pre-existing dilative or ischemic heart disease with EF<35% and guideline indication for spironolactone
- 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
- Known planned operations or catheter-based interventions (e.g. PCI, transcatheter edge-to-edge mitral or tricuspid valve repair) during 3 months after study inclusion; the performance of e.g. PCI immediately before study enrolment and before TAVI is possible
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.