Clinical trial

Hemodynamic Effects of Angiotensin Receptor Neprilysin Inhibition on Noninvasive Pressure-volume Analysis in Patients With Heart Failure With Reduced Ejection Fraction

Name
DL-L-20005_V1.4
Description
Sacubitril-Valsartan reduced heart failure hospitalizations and cardiovascular mortality compared to enelapril in chronic heart failure. Furthermore, quality of life is improved. The decrease of NT-proBNP levels during Sacubitril-Valsartan treatment is associated with reverse left ventricular remodeling and improved left ventricular systolic function. However, the underlying mechanisms that contribute to these symptomatic and prognostic benefits are largely unknown. The aim of this study is to evaluate left ventricular hemodynamics in patients treated with Sacubitril-Valsartan using non-invasive pressure-volume analysis.
Trial arms
Trial start
2020-07-21
Estimated PCD
2025-12-31
Trial end
2025-12-31
Status
Active (not recruiting)
Treatment
Sacubitril-Valsartan
Observational study during the clinically indicated treatment
Size
117
Primary endpoint
Left ventricular contractility, afterload and ventricular-arterial coupling
6 months
Eligibility criteria
Inclusion Criteria: * Symptomatic heart failure (NYHA functional class II to IV) * Reduced LV ejection fraction (≤ 40%) * Clinical indication for therapy with Sacubitril-Valsartan Exclusion Criteria: * catecholamine therapy at inclusion * existing therapy with Sacubitril-Valsartan * planned cardiac resynchronization therapy (CRT) within 6 months; inclusion at least 3 months after CRT * planned mitral or aortic valve procedure within 6 months; inclusion at least 3 months after valve procedure * participation in another randomized heart failure trial * severe aortic or mitral valve lesion
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '12 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 117, 'type': 'ACTUAL'}}
Updated at
2023-05-12

1 organization

1 product

1 indication