Effect of antifibrotic therapy on regression of myocardial fibrosis after transcatheter aortic valve implantation (TAVI) in aortic stenosis patients with high fibrotic burde

Phase 2

• Conditions: I50; Heart failure

• Registration Number: DRKS00019893
• Lead Sponsor: niversitätsmedizin Göttingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Male, female age = 60
2. Diagnosis of severe symptomatic aortic stenosis
3. Transcatheter aortic valve implantation (TAVI) scheduled
4. Myocardial fibrosis verified by left-ventricular biopsy (criterion for randomization: level of myocardial fibrosis = 11%)
5. Written informed consent

Exclusion Criteria

1. Ejection fraction <35% as measured by TTE 2-7 days post-TAVI
2. Pacemaker or ICD implanted
3. Renal impairment (serum creatinine > 2mg/dl)
4. Significant hypotension (blood pressure < 90 mm Hg systolic and/or < 50 mm Hg diastolic
5. Serum potassium > 5,1 mmol/l
6. Spironolactone or Dihydralazine contraindicated
7. Known active malignant disease
8. Women with child-bearing potential
9. Simultaneous participation (including a waiting period of 4 weeks) in other interventional clinical trials
10. Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial,
11. Person who is in a relationship of dependence/employment with the sponsor or the investigator

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>Differences between treatment groups at 12 months in MRI measurements of late gadolinium enhancement (LGE) and extra-cellular volume fraction (ECV).