Sacubitril Valsartan vs. Angiotensin Converting Enzyme Inhibitor for chronic rheumatic mitral regurgitatio
- Conditions
- Health Condition 1: I051- Rheumatic mitral insufficiency
- Registration Number
- CTRI/2020/12/029913
- Lead Sponsor
- All India Institute of Medical Science Rishikesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Asymptomatic or minimally symptomatic rheumatic severe mitral regurgitation
Not a candidate for surgery
History of hypersensitivity or allergy to the study drug or contraindications to the study drug
Known history of angioedema
Current acute decompensated heart failure or dyspnea of NYHA class
Medical history of hospitalization within 6 weeks
Symptomatic hypotension and/or a SBP < 100 mmHg at screening
Estimated GFR < 30 mL/min/1.73m2
Serum potassium > 5 mmol/L at screening
Evidence of hepatic disease as determined by any one of the f ALT values exceeding 2 x upper limit of normal (ULN) at screen history of hepatic encephalopathy, history of esophageal varice portacaval shunt
Acute coronary syndrome, stroke, major CV surgery, Percutaneous intervention
Planned coronary revascularization or mitral valve intervention
Heart transplantation or implantation of cardiac resynchronization
History of severe pulmonary disease
Significant aortic valve disease
Primary aldosteronism
Women of child-bearing potential, defined as all women physio capable of becoming pregnant, unless they are using a barrier hormonal method
Pregnant or nursing (lactating) women
Any clinically significant abnormality identified at the screening examination, laboratory tests, or electrocardiogram which, the the investigator, would preclude safe completion of the study
Atrial Fibrillation
Pulmonary Artery Pressure > 50 mm Hg 20 . LV end systolic dimension > 40 mm 21. LVEF < 50 %
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of effective regurgitant orifice area of mitral regurgitationTimepoint: Change of effective regurgitant orifice area of mitral regurgitation
- Secondary Outcome Measures
Name Time Method Change of N-terminal of the prohormone brain natriuretic peptide)Timepoint: 12 months;Change of left ventricular end-diastolic volumeTimepoint: 12 months;Change of left ventricular end-systolic volumeTimepoint: 12 months;Change of left ventricular global longitudinal strainTimepoint: 12 months;Change of <br/ ><br>regurgitant volume of mitral regurgitationTimepoint: 12 months