Sacubitril-Valsartan in Heart Failure with Preserved Ejection Fraction and Secondary Mitral Valve Regurgitation (PRAISE-MR)

Ziekenhuis Oost Limburg0 sites110 target enrollmentJuly 17, 2023

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Heart failure with preserved ejection fraction Secundary mitral valve regurgitation
Sponsor: Ziekenhuis Oost Limburg
Enrollment: 110
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

July 17, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•(1\) Age \> 18 years (2\) NYHA class II to IV (3\) Written informed consent (4\) Left ventricular ejection fraction \= 50% (5\) Objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/raised LV filling pressures\*, including raised natriuretic peptides\*\* (6\) \= moderate functional MR assessed by TTE within the previous year

•(1\) Systolic blood pressure \< 100 mmHg (2\) Potassium \= 5\.2 mmol/L (3\) eGFR \= 25 ml/min/1\.73m² (4\) History of angioedema or unacceptable side effects during receipt of ACE inhibitors or ARBs (5\) Structural mitral valve disease and previous or planned mitral valve intervention (6\) Already receiving ARNI (sacubitril\-valsartan) therapy (7\) Severe comorbid condition limiting life expectancy \< 24 months or inability to perform a maximal CPETecho