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Completed

NCT Number: NCT04498780

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

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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Key information

Conditions

Heart Failure With Reduced Ejection Fraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Leipzig, Leipzig, Saxony, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sacubitril-valsartan

Drug

Observational study during the clinically indicated treatment

Primary outcomes

  1. Left ventricular contractility, afterload and ventricular-arterial coupling

    Time frame: 6 months

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

Secondary outcomes

  1. Systolic and diastolic LV function, symptom status and biomarkers

    Time frame: 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

  2. Left ventricular contractility, afterload and ventricular-arterial coupling

    Time frame: 3 and 12 months

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

Other outcomes

  1. Load-independent parameters of systolic and diastolic LV function, myocardial work indices

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

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

Acronym: ARNI-PVA

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Aug 4, 2020
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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