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Completed

NCT Number: NCT05991284

Sacubitril-Valsartan in Heart Failure With Preserved Ejection Fraction and Secondary Mitral Valve Regurgitation

The main objective of this study is to assess the hemodynamic effects of sacubitril-valsartan in patients with heart failure with preserved ejection fraction and at least moderate atrial functional mitral regurgitation (AFMR), using a combination of cardiopulmonary exercise testing and stress echocardiography (referred to as CPETecho) at baseline and after six months of therapy. The patients included in this study will be randomly assigned to receive sacubitril-valsartan as an adjunct to standard medical care, as opposed to adhering solely to the standard of care which involves sodium-glucose cotransporter-2 (SGLT-2) inhibitor and mineralocorticoid receptor antagonist (MRA).

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Key information

Conditions

Heart Failure With Preserved Ejection Fraction Functional Mitral Regurgitation

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years.
  • New York Heart Association class II to IV.
  • Written informed consent.
  • Left ventricular (LV) ejection fraction ≥ 50%.
  • 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.
  • ≥ moderate functional MR assessed by transthoracic echocardiography within the previous year.

Exclusion criteria

  • Systolic blood pressure < 100 mmHg.
  • Potassium ≥ 5.2 mmol/L.
  • Estimated Glomerular Filtration Rate ≤ 25 ml/min/1.73m².
  • History of angioedema or unacceptable side effects during receipt of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB).
  • Structural mitral valve disease and previous or planned mitral valve intervention.
  • Already receiving angiotensin receptor neprilysin inhibitor (ARNI, sacubitril-valsartan) therapy.
  • Severe comorbid condition limiting life expectancy < 24 months or inability to perform a maximal CPETecho.
  • Myocardial infarction, unstable angina, coronary revascularization within 12 weeks prior enrolment.
  • Severe aortic, tricuspid or pulmonary valve disease.
  • Pregnancy, lactation, or use of any method of contraception that is not highly effective.

Treatment and study plan

Sacubitril-valsartan

Drug

sacubitril-valsartan (target dose 97/103 mg twice daily)

Standard of care

Drug

including SGLT-2 inhibitor and MRA

Primary outcomes

  1. Change in mean pulmonary arterial pressure over cardiac output slope assessed by CPETecho

    Time frame: Six months of treatment

Secondary outcomes

  1. Change in peak oxygen uptake

    Time frame: Six months of treatment

  2. Change in mitral effective regurgitant orifice area (EROA)

    Time frame: Six months of treatment

  3. Change in natriuretic peptide levels

    Time frame: Six months of treatment

  4. Change in left atrial volume (LAVI)

    Time frame: Six months of treatment

  5. Change the minute ventilation over carbon dioxide production slope

    Time frame: Six months of treatment

  6. Change in patient reported outcomes (Kansas City Cardiomyopathy Questionnaire, KCCQ-12)

    Time frame: Six months of treatment

  7. Change in left atrial function (peak atrial longitudinal strain, PALS)

    Time frame: Six months of treatment

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Collaborators

  • Jessa Hospital

Registry information

Acronym: PRAISE-MR

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 14, 2023
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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