Sacubitril-Valsartan in Heart Failure with Preserved Ejection Fraction and Secondary Mitral Valve Regurgitation (PRAISE-MR)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506634-70-00

Enrollment

110

Registered

2023-10-11

Start date

2024-02-29

Completion date

Unknown

Last updated

2023-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure with preserved ejection fraction Secundary mitral valve regurgitation

Brief summary

Change in the mPAP/CO slope between randomization and 6 months thereafter

Detailed description

Changes in (1) Peak VO2 (2) Mitral effective regurgitant orifice area (EROA) (3) Natriuretic peptide levels (NTproBNP) (4) Left atrial volume (Left Atrial Volume Index, LAVI) (5) Left atrial function (Peak Atrial Longitudinal Strain, PALS) (6) VE/VCO2 slope (7) Patient reported outcomes (Kansas City Cardiomyopathy Questionnaire, KCCQ-12)

Interventions

DRUGEntresto 97 mg/103 mg film-coated tablets

DRUGEntresto 24 mg/26 mg film-coated tablets

DRUGEntresto 49 mg/51 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in the mPAP/CO slope between randomization and 6 months thereafter	—

Secondary

Measure	Time frame
Changes in (1) Peak VO2 (2) Mitral effective regurgitant orifice area (EROA) (3) Natriuretic peptide levels (NTproBNP) (4) Left atrial volume (Left Atrial Volume Index, LAVI) (5) Left atrial function (Peak Atrial Longitudinal Strain, PALS) (6) VE/VCO2 slope (7) Patient reported outcomes (Kansas City Cardiomyopathy Questionnaire, KCCQ-12)	—

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026