Last updated: January 27, 2022
Sponsor: Samsung Medical Center
Overall Status: Active - Recruiting
Phase
2
Condition
N/ATreatment
N/AClinical Study ID
NCT05212597
reverseAR
Ages 20-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
- NYHA I
- 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
Exclusion Criteria:
- A history of hypersensitivity or allergy to clinical trial drugs or similar compoundsor 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 (Marfansyndrome, Ehlers-Danlos syndrome)
- Patients with moderate to severe aortic stenosis
- Patients with claustrophobia or with metallic implants unsuitable for magneticresonance 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 andsigns of cirrhosis (history of hepatic coma, history of esophageal varices, history ofsymptomatic ascites)
- In case of acute coronary syndrome, stroke, thoracic surgery, and percutaneouscoronary 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 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
Connect with a study center
Samsung Medical Center
Seoul, 06351
Korea, Republic ofActive - Recruiting

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