I50
Conditions
Interventions
Group 1: Control treatment: Standard of care
Group 2: standard of care + Spironolactone (25 mg/d, p.o.)
Group 3: standard of care + Spironolactone (25 mg/d, p.o.) + Dihydralazine (2x12.5 mg/d p.o. i
Sponsors
Universitätsmedizin Göttingen
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
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
Exclusion criteria: 1. Ejection fraction 2mg/dl) 4. Significant hypotension (blood pressure 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Differences between treatment groups at 12 months in MRI measurements of late gadolinium enhancement (LGE) and extra-cellular volume fraction (ECV). | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoint(s): 1. To determine the effects of antifibrotic therapy on reverse left ventricular remodelling (measured by transthoracic echocardiography and MRI) in patients with baseline high fibrotic burden: - Differences in recovery of ejection fraction (EF) at month 12 - Differences in recovery of global longitudinal strain (GLS) at month 12 - Differences in reduction of left ventricular mass at month 12 - Differences in reduction of left ventricular volumes at month 12 2. To determine the effects of antifibrotic therapy on quantitative measures of heart failure in patients with baseline high fibrotic burden: - Differences in quality of life according to Minnesota living with heart failure ® Quality of Life Questionnaire (MLHFQLQ) at month 12 - Differences in 6min-walking test distance (6MWT) at month 12 - Differences in NT-proBNP-levels at month 12 3. To determine the effects of antifibrotic therapy on cardiovascular mortality in patients with baseline high fibrotic burden - Differences in cardiovascular 12-month mortality 4. To evaluate the potential of blood biomarkers of myocardial fibrosis (PICP, PIIINP) to predict histological or MRI myocardial fibrosis and/ or fibrosis regression measured by MRI. Assessment of safety: Standard procedures for safety monitoring including AEs/ SAEs applied. | — |
Countries
Germany
Contacts
Public ContactGerd Hasenfuß
Klinik für Kardiologie und Pneumologie
Outcome results
None listed