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

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Amlodipine; Losartan; Sacubitril and valsartan sodium hydrate drug combination; Valsartan

Criteria

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 Criteria:

1. A history of hypersensitivity or allergy to clinical trial drugs or similar compounds or 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 (Marfan syndrome, Ehlers-Danlos syndrome)

5. Patients with moderate to severe aortic stenosis

6. Patients with claustrophobia or with metallic implants unsuitable for magnetic resonance 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 and signs of cirrhosis (history of hepatic coma, history of esophageal varices, history of symptomatic ascites)

12. In case of acute coronary syndrome, stroke, thoracic surgery, and percutaneous coronary 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 physical examination, diagnostic examination, electrocardiogram, etc. at the time of the screening visit