Efficacy of Angiotensin Receptor Blocker Following aortIc Valve Intervention for Aortic STenOsis: a Randomized mulTi-cEntric Double-blind Phase II Study (ARISTOTE)
Aortic Valve Stenosis, Valsartan, Angiotensin Receptor Antagonists
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Aortic Valve Stenosis, Valsartan, Angiotensin Receptor Antagonists, Transcatheter Aortic Valve Replacement, Heart Valve Prosthesis Implantation, double-blind phase II study, left ventricular mass
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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 Exclusion Criteria:
- Patients not under RAASb prior to randomization but who should benefit from this treatment to improve outcome:
- Heart failure with reduced ejection fraction (<40%)
- Coronary artery disease
- Clinical peripheral artery disease
- History of cerebrovascular disease
- Uncontrolled hypertension despite the use of other therapeutic classes
- Diabetes mellitus
- Impossibility to perform randomization into the 9-day post-intervention period due to per procedural complication with prolonged stay in intensive cardiac care unit (including death).
Sites / Locations
- Limoges university hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Valsartan
Placebo Oral Tablet
The active treatment is valsartan, an orally active, potent, and specific angiotensin II receptor antagonist. The treatment will be initiated (80 mg, daily) at 5±4 days following aortic valve intervention. The dose will be increased at 160 mg daily 13±2 days after aortic valve intervention and, if well tolerated, for the remaining period of the study.
The comparative treatment will be a placebo; tablets of valsartan and placebo have a similar appearance and administration mode. Patient in the control group will receive a placebo using the same protocol as the valsartan group.