Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT03315832
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03315832
Study Brief:
Protocol Section:
NCT03315832