drugset / Trial / NCT02687932

Pharmacological Reduction of Functional, Ischemic Mitral REgurgitation

NCT02687932

Phase 4 Completed 118 enrolled Asan Medical Center Novartis · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Functional MR is caused by adverse left ventricular remodeling after myocardial injury and associated with an increased incidence of heart failure and death. Because secondary functional MR usually develops as a result of LV dysfunction, diuretics, beta blockers, angiotensin-converting-enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB), and aldosterone antagonists are given to patients with functional MR in line with the guidelines in the management of heart failure. However, functional MR appears to remain common despite use of these drugs and current medical treatment is usually insufficient for reducing MR or reversing the adverse LV remodeling. As LCZ696 is a dual-acting inhibitor of the renin-angiotensin-aldosterone system (RAAS) and neutral endopeptidase (NEP), LCZ696 has greater hemodynamic and neurohormonal effects than ARB alone. Investigators try to examine the hypothesis that LCZ696 is superior to ARB alone in improving functional MR in patients with LV dysfunction and functional MR.

Timeline

Start
2016-03
Primary completion
2018-01-02
Completion
2018-01-02

Drugs

EvaluationDrugModalityDoseRoute
Subject LCZ696 Unknown
Comparator Valsartan Small molecule