PRAISE-MR trial
- Conditions
- Heart failure with preserved ejection fraction Secundary mitral valve regurgitationTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-506634-70-00
- Lead Sponsor
- Ziekenhuis Oost Limburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 110
(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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method