PRAISE-MR trial
Key facts
- Where
- Genk and Hasselt, BelgiumSee the 2 sites
- Phase
- Phase 4
Where in Belgium
- Ziekenhuis Oost-LimburgGenk, BelgiumNo longer taking part
- JESSA ZiekenhuisHasselt, BelgiumNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ziekenhuis Oost Limburg
- Trial code
- EU 2023-506634-70-00
- Record updated
- 11 October 2023
- Original description
The main objective of this study is to assess the hemodynamic effects of sacubitril-valsartan in patients with HFpEF and secondary / atrial functional mitral regurgitation (AFMR), using a combination of cardiopulmonary exercise testing and stress echocardiography (referred to as CPETecho). Secondary endpoints include the changes in quantitative valve assessment (EROA), quality of life and different CPETecho parameters.Read full original descriptionShow less
Sacubitril-Valsartan in Heart Failure with Preserved Ejection Fraction and Secondary Mitral Valve Regurgitation (PRAISE-MR)
The main objective of this study is to assess the hemodynamic effects of sacubitril-valsartan in patients with HFpEF and secondary / atrial functional mitral regurgitation (AFMR), using a combination of cardiopulmonary exercise testing and stress echocardiography (referred to as CPETecho). Secondary endpoints include the changes in quantitative valve assessment (EROA), quality of life and different CPETecho parameters.
Inclusion: (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.
Exclusion: (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.