Status:
WITHDRAWN
Efficacy of Angiotensin Receptor Blocker Following aortIc Valve Intervention for Aortic STenOsis: a Randomized mulTi-cEntric Double-blind Phase II Study
Lead Sponsor:
University Hospital, Limoges
Conditions:
Aortic Valve Stenosis
Valsartan
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Aortic stenosis (AS) is the most frequent valvular heart disease in Western countries, with increasing prevalence. Recent guidelines recommend aortic valve intervention (surgical aortic valve replacem...
Eligibility Criteria
Inclusion
- Men with age ≥18 years
- Women at postmenopausal state as defined by absence of menses for the last 12 months without alternative medical cause.
- Severe AS, defined according most recent guidelines (aortic valve area \<1.0cm² or \<0.6cm²/m² and aortic mean pressure gradient ≥40mmHg or aortic maximal velocity \>4m/s, as assessed using transthoracic echocardiography \[TTE\]).
- Indication for aortic valve intervention
- Affiliation to the French Social Security system
- Signed informed consent.
Exclusion
- Patients already under any Renin-Angiotensin-Aldosterone System blockers (RAASb) prior to randomization.
- Concomitant coronary artery bypass graft or other valvular intervention
- Other significant left-sided valvular heart diseases (≥moderate), even without concomitant procedure
- Any contra-indication to CMR
- Chronic kidney disease with estimated glomerular filtration rate (GFR) \<30 ml/min
- Prior or planned organ transplantation
- Hyperkaliemia (kaliemia \>5.5 mmol/L at inclusion visit)
- Severe hepatic failure, biliary cirrhosis, cholestasis
- Combined use of aliskiren and concomitant diabetes mellitus or renal failure with GFR\<60mL/min/1.73m²
- Low systolic blood pressure (\<100mmHg)
- History of angioedema
- History of hypersensitivity or allergy to Angiotensin-II Receptor Blockers or excipient
- Under legal authority.
- Unwilling to consent
- Secondary
Key Trial Info
Start Date :
January 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03315832
Start Date
January 2 2023
End Date
July 2 2025
Last Update
March 17 2023
Active Locations (1)
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1
Limoges university hospital
Limoges, France, 87042