Status:
UNKNOWN
Sacubitril/Valsartan Versus Valsartan in Heart Failure With Improved Ejection Fraction
Lead Sponsor:
Samsung Medical Center
Conditions:
Heart Failure, Systolic
Eligibility:
All Genders
18+ years
Brief Summary
Heart failure (HF) is a chronic disease with weakened heart muscles or abnormal pressure within the heart chambers result in breathlessness, leg edema, or fatigue. A subclass of HF shows reduced heart...
Detailed Description
1\. Background and study purpose Heart failure (HF) is caused by structural or functional abnormality of the myocardium or elevated intracardiac pressures, resulting in symptoms and signs of low cardi...
Eligibility Criteria
Inclusion
- (AND)
- Patient with a history of HF with reduced EF (HFrEF; LVEF \<40 percent) and received treatment with sacubitril/valsartan for at least 3 months, after which showing improvement of LVEF to \>40 percent and symptoms of NYHA functional class I or II
- serum NT-proBNP levels \< 400 pg/dL for sinus rhythm and \< 600pg/dL for atrial fibrillation
- Patients on stable doses of diuretics for 1 week
Exclusion
- (OR)
- History of hospitalization for heart failure within 30 days before enrollment
- History of acute coronary syndrome (acute myocardial infarction or unstable angina), percutaneous coronary artery intervention or cardiac surgery within 30 days before enrollment
- History of cardiac resynchronization therapy within 90 days before screening
- Planned percutaneous or surgical coronary artery revascularization, or major cardiac surgery (coronary artery bypass, valvuloplasty, mechanical cardiac support or heart transplantation) within 90 days after enrollment
- Contraindicated or has history of hypersensitivity to RAS blockers including ACEI or ARB
- Use of inotropes
- Survival estimate \< 3months
- Otherwise deemed as inappropriate by the attending physician
Key Trial Info
Start Date :
March 16 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04803175
Start Date
March 16 2021
End Date
February 1 2025
Last Update
August 18 2021
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 06351