Hemodynamic Effects of ARNI on Noninvasive Pressure-volume Analysis in Patients With Chronic Heart Failure (ARNI-PVA)

University of Leipzig

Status: Active, not recruiting

Conditions: Heart Failure With Reduced Ejection Fraction

Treatments: Drug: Sacubitril-Valsartan

Study type: Observational

Funder types: Other

Identifiers

NCT04498780

DL-L-20005_V1.4

Details and patient eligibility

About

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.

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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