Open Label RCT for Chronic Severe AR : Entresto vs. CCB/ARB

Last updated: January 27, 2022
Sponsor: Samsung Medical Center
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05212597
reverseAR
  • Ages 20-90
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. A history of hypersensitivity or allergy to clinical trial drugs or similar compoundsor ARB/NEP inhibitors
  2. History of angioedema
  3. Patients with an ascending aorta dilated by more than 55 mm
  4. Patients with aortic valve insufficiency due to hereditary aortic disease (Marfansyndrome, Ehlers-Danlos syndrome)
  5. Patients with moderate to severe aortic stenosis
  6. Patients with claustrophobia or with metallic implants unsuitable for magneticresonance imaging
  7. History of acute heart failure within 6 weeks and dyspnea of NYHA II or higher
  8. Symptomatic hypotension or SBP < 100 mmHg at screening
  9. Patients with renal failure (Estimated GFR < 30 mL/min/1.73 m2) or on dialysis
  10. Significant increase in blood potassium level (Potassium > 5 mmol/L)
  11. Blood AST or ALT value is more than twice the upper limit of normal or symptoms andsigns of cirrhosis (history of hepatic coma, history of esophageal varices, history ofsymptomatic ascites)
  12. In case of acute coronary syndrome, stroke, thoracic surgery, and percutaneouscoronary angioplasty within 3 months
  13. If aortic valve surgery is scheduled within the next 6 months
  14. In case of severe mitral valve disease
  15. Patients with primary hyperaldosteronism
  16. If a woman of childbearing potential has not used double contraception
  17. Women who are currently pregnant or lactating
  18. When it is judged that there are clinically significant abnormalities in physicalexamination, diagnostic examination, electrocardiogram, etc. at the time of thescreening visit

Study Design

Total Participants: 100
Study Start date:
January 12, 2022
Estimated Completion Date:
December 31, 2024

Study Description

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.

Connect with a study center

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

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