Open Label RCT for Chronic Severe AR : Entresto vs. CCB/ARB (REVERSE-AR)

  • End date
    Dec 23, 2024
  • participants needed
  • sponsor
    Samsung Medical Center
Updated on 23 March 2022
ejection fraction


The purpose of this study is to assess the efficacy of sacubitril-valsartan compared to the combination of ARB/CCB on left ventricular remodeling in patients with chronic aortic valve regurgitation.


After being informed consent about the study and potential risk, all patients giving written informed consent will undergo a 1 month screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in an open-label manner in a 1:1 ratio to sacubitril-valsartan or amlodipine/losartan.

Condition Aortic Valve Insufficiency
Treatment Sacubitril-Valsartan, Amlodipine-losartan
Clinical Study IdentifierNCT05212597
SponsorSamsung Medical Center
Last Modified on23 March 2022


Yes No Not Sure

Inclusion Criteria

Participant over 20 years of age who has not been hospitalized for heart failure
Participant with hypertension or systolic blood pressure 125 mmHg or higher
Participant with chronic severe aortic regurgitation (VCW >0.6cm)
Participant with AV regurgitant volume ≥ 60mL or effective regurgitant orifice area ≥ 0.3 cm2
Participant with left ventricular ejection fraction ≥ 55%

Exclusion Criteria

A history of hypersensitivity or allergy to clinical trial drugs or similar compounds or ARB/NEP inhibitors
History of angioedema
Patients with an ascending aorta dilated by more than 55 mm
Patients with aortic valve insufficiency due to hereditary aortic disease (Marfan syndrome, Ehlers-Danlos syndrome)
Patients with moderate to severe aortic stenosis
Patients with claustrophobia or with metallic implants unsuitable for magnetic resonance imaging
History of acute heart failure within 6 weeks and dyspnea of NYHA II or higher
Symptomatic hypotension or SBP < 100 mmHg at screening
Patients with renal failure (Estimated GFR < 30 mL/min/1.73 m2) or on dialysis
Significant increase in blood potassium level (Potassium > 5 mmol/L)
Blood AST or ALT value is more than twice the upper limit of normal or symptoms and signs of cirrhosis (history of hepatic coma, history of esophageal varices, history of symptomatic ascites)
In case of acute coronary syndrome, stroke, thoracic surgery, and percutaneous coronary angioplasty within 3 months
If aortic valve surgery is scheduled within the next 6 months
In case of severe mitral valve disease
Patients with primary hyperaldosteronism
If a woman of childbearing potential has not used double contraception
Women who are currently pregnant or lactating
When it is judged that there are clinically significant abnormalities in physical examination, diagnostic examination, electrocardiogram, etc. at the time of the screening visit
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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