Status:
ACTIVE_NOT_RECRUITING
Sacubitril-Valsartan in Heart Failure With Preserved Ejection Fraction and Secondary Mitral Valve Regurgitation
Lead Sponsor:
Ziekenhuis Oost-Limburg
Collaborating Sponsors:
Jessa Hospital
Conditions:
Heart Failure With Preserved Ejection Fraction
Functional Mitral Regurgitation
Eligibility:
All Genders
18-95 years
Phase:
PHASE4
Brief 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 mi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05991284
Start Date
February 29 2024
End Date
May 1 2026
Last Update
December 19 2025
Active Locations (1)
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1
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600