Health Condition 1: I051- Rheumatic mitral insufficiency
Conditions
Interventions
Intervention1: Sacubitril Valsartan: Following randomization, patients will receive oral sacubitril/valsartan in titrated
doses from level 1 up to level 3 (50, 100 and 200 mg twice daily) for 1 year
C
Sponsors
All India Institute of Medical Science Rishikesh
Eligibility
Inclusion criteria
Inclusion criteria: Asymptomatic or minimally symptomatic rheumatic severe mitral regurgitation Not a candidate for surgery
Exclusion criteria
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 Estimated GFR 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 %
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of effective regurgitant orifice area of mitral regurgitationTimepoint: Change of effective regurgitant orifice area of mitral regurgitation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 regurgitant volume of mitral regurgitationTimepoint: 12 months | — |
Countries
India
Contacts
Public ContactRohit Walia
All India Institute of Medical Science Rishikesh
Outcome results
None listed