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Sacubitril Valsartan vs. Angiotensin Converting Enzyme Inhibitor for chronic rheumatic mitral regurgitatio

Phase 3
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
Inclusion Criteria

Asymptomatic or minimally symptomatic rheumatic severe mitral regurgitation

Not a candidate for surgery

Exclusion Criteria

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
NameTimeMethod
Change of effective regurgitant orifice area of mitral regurgitationTimepoint: Change of effective regurgitant orifice area of mitral regurgitation
Secondary Outcome Measures
NameTimeMethod
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
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