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

NCT04498780 — Completed, 117 participants, University of Leipzig

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

Registry	NCT04498780, acronym ARNI-PVA
Status	Completed
Study type	Observational
Enrollment	117 (Actual)
Sponsor	University of Leipzig (Other)
Conditions	Heart Failure With Reduced Ejection Fraction
Interventions	Sacubitril-Valsartan (Drug)
Dates	start 2020-07-21, primary completion 2025-12-31, completion 2026-04-08, first posted 2020-08-04, last updated 2026-04-08
Locations	2 sites in Germany

-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.

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+Arms and interventions

Sacubitril-Valsartan (Drug): Observational study during the clinically indicated treatment

+Outcome measures

Primary outcomes

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 outcomes

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)

Other outcomes

Load-independent parameters of systolic and diastolic LV function, myocardial work indices [3, 6 and 12 months]: * Peak power index (PPI) * Preload-recruitable stroke work (PRSW) * End-systolic meridional wall stress (EsMWS) * Total peripheral resistance (TPR) * LV end-systolic pressure (LVEDP) * LV end-diastolic pressure-volume relationship (LVEDPVR) * Pressure-strain loops

+Eligibility

Sex: All, ages: 18 Years to any

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)

Facility	City	Country	Status
University of Leipzig	Leipzig, Saxony	Germany
Kardiopraxis Schirmer	Kaiserslautern	Germany

+Investigators

Daniel Lavall, MD, Principal investigator, University of Leipzig

My Notes

Public

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