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

University of Leipzig117 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

117

Conditions

Heart Failure With Reduced Ejection Fraction

Interventions

Sacubitril-ValsartanDRUG

Observational study during the clinically indicated treatment

Eligibility

Medical Language ↔ Plain English

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

Locations (2)

University of Leipzig

Leipzig, Saxony, Germany

Kardiopraxis Schirmer

Kaiserslautern, Germany

Outcomes

Primary Outcomes

Left ventricular contractility, afterload and ventricular-arterial coupling

Change of end-systolic elastance (Ees), arterial elastance (Ea) and ventricular-arterial coupling (Ea/Ees)

Time frame: 6 months

Secondary Outcomes

Systolic and diastolic LV function, symptom status and biomarkers

* Echocardiography: Left ventricular (LV) remodeling und function (LVEDV, LVESV, LVEF, GLS), diastolic LV function (LAESV, E/e', LVEDP) * Symptoms: NYHA functional class, 6 minute walk test * Biomarker: NT-proBNP

Time frame: 3, 6 and 12 months

Left ventricular contractility, afterload and ventricular-arterial coupling

Change of end-systolic elastance (Ees), arterial elastance (Ea) and ventricular-arterial coupling (Ea/Ees)

Time frame: 3 and 12 months