Heart Failure With Preserved Ejection FractionPhase 4PRAISE-MRNCT05991284
Sacubitril-Valsartan in Heart Failure With Preserved Ejection Fraction and Secondary Mitral Valve Regurgitation
A Phase 4 study testing Sacubitril-valsartan in people with Heart Failure With Preserved Ejection Fraction and Functional Mitral Regurgitation, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Functional Mitral Regurgitation
- What is being tested?
- Sacubitril-valsartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Feb 2024to 9 May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Being tested
- Sacubitril-valsartan, Standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril-valsartanDrug
sacubitril-valsartan (target dose 97/103 mg twice daily)
Standard of careDrug
including SGLT-2 inhibitor and MRA
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Active comparator | Sacubitril-Valsartan (target dose 97/103 mg twice daily) on top of standard of care (including SGLT-2 inhibitor and MRA) Receives: Drug: Sacubitril-valsartan; Drug: Standard of care |
| Control arm | Placebo comparator | Standard of care (including SGLT-2 inhibitor and MRA) Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean pulmonary arterial pressure over cardiac output slope assessed by CPETecho
Measured: Six months of treatment
Secondary outcomes (7)
Change in peak oxygen uptake
Measured: Six months of treatment
Change in mitral effective regurgitant orifice area (EROA)
Measured: Six months of treatment
Change in natriuretic peptide levels
Measured: Six months of treatment
Change in left atrial volume (LAVI)
Measured: Six months of treatment
Change the minute ventilation over carbon dioxide production slope
Measured: Six months of treatment
Change in patient reported outcomes (Kansas City Cardiomyopathy Questionnaire, KCCQ-12)
Measured: Six months of treatment
Change in left atrial function (peak atrial longitudinal strain, PALS)
Measured: Six months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start29 Feb 2024
- Primary completion22 Sep 2025
- Study completion9 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, Investigator-initiated, Prospective, Randomized trial with Open Blinded Endpoint
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991284
- Sponsor's protocol ID
- Z-2023036
- Acronym
- PRAISE-MR
- Status last verified
- Jun 2026
- First submitted
- 1 Aug 2023
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dhont S, Moura Ferreira S, Galloo X, Martens P, Meekers E, Tartaglia K, Deferm S, Herbots L, Mullens W, Verbrugge FH, Verwerft J, Bertrand PB. Angiotensin Receptor Neprilysin Inhibitor in Heart Failure With Preserved Ejection Fraction and Secondary Mitral Regurgitation: The PRAISE-MR Randomized Trial. Circulation. 2026 Jun 23;153(25):1973-1983. doi: 10.1161/CIRCULATIONAHA.126.080833. Epub 2026 May 9.
PubMed 42104906
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacubitril-Valsartan in Heart Failure With Preserved Ejection Fraction and Secondary Mitral Valve Regurgitation
- ClinicalTrials.gov ID
- NCT05991284
- Acronym / sponsor ID
- PRAISE-MR / Z-2023036
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 9 May 2026 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, Investigator-initiated, Prospective, Randomized trial with Open Blinded Endpoint
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Active comparator | Drug: Sacubitril-valsartan, Drug: Standard of careSacubitril-Valsartan (target dose 97/103 mg twice daily) on top of standard of care (including SGLT-2 inhibitor and MRA) |
| Control arm | Placebo comparator | Drug: Standard of careStandard of care (including SGLT-2 inhibitor and MRA) |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacubitril-valsartansacubitril-valsartan (target dose 97/103 mg twice daily) | Drug | Intervention arm |
| Standard of careincluding SGLT-2 inhibitor and MRA | Drug | Control arm, Intervention arm |
Primary outcome
Change in mean pulmonary arterial pressure over cardiac output slope assessed by CPETecho
Time frame: Six months of treatment
7 secondary outcomes
Change in peak oxygen uptake
Time frame: Six months of treatment
Change in mitral effective regurgitant orifice area (EROA)
Time frame: Six months of treatment
Change in natriuretic peptide levels
Time frame: Six months of treatment
Change in left atrial volume (LAVI)
Time frame: Six months of treatment
Change the minute ventilation over carbon dioxide production slope
Time frame: Six months of treatment
Change in patient reported outcomes (Kansas City Cardiomyopathy Questionnaire, KCCQ-12)
Time frame: Six months of treatment
Change in left atrial function (peak atrial longitudinal strain, PALS)
Time frame: Six months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Derived from this study: PubMed 42104906Dhont S, Moura Ferreira S, Galloo X, Martens P, Meekers E, Tartaglia K, Deferm S, Herbots L, Mullens W, Verbrugge FH, Verwerft J, Bertrand PB. Angiotensin Receptor Neprilysin Inhibitor in Heart Failure With Preserved Ejection Fraction and Secondary Mitral Regurgitation: The PRAISE-MR Randomized Trial. Circulation. 2026 Jun 23;153(25):1973-1983. doi: 10.1161/CIRCULATIONAHA.126.080833. Epub 2026 May 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sacubitril-valsartan in people with Heart Failure With Preserved Ejection Fraction and Functional Mitral Regurgitation, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean pulmonary arterial pressure over cardiac output slope assessed by CPETecho (time frame: Six months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05991284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.