PRAISE-MR trial
EU CTIS ID: 2023-506634-70-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- (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
You likely can't join if
- (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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.