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

Active, not recruiting

• Conditions: Heart Failure With Reduced Ejection Fraction

• Registration Number: NCT04498780
• Lead Sponsor: University of Leipzig

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-21
• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-07-30
• Study First Posted: 2020-08-04
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-12
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 117

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Left ventricular contractility, afterload and ventricular-arterial coupling	6 months	Change of end-systolic elastance (Ees), arterial elastance (Ea) and ventricular-arterial coupling (Ea/Ees)

Secondary Outcome Measures

Name	Time	Method
Systolic and diastolic LV function, symptom status and biomarkers	3, 6 and 12 months	* 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
Left ventricular contractility, afterload and ventricular-arterial coupling	3 and 12 months	Change of end-systolic elastance (Ees), arterial elastance (Ea) and ventricular-arterial coupling (Ea/Ees)

Trial Locations

Locations (2)

University of Leipzig; 🇩🇪 Leipzig, Saxony, Germany

Kardiopraxis Schirmer; 🇩🇪 Kaiserslautern, Germany