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CompletedNCT04498780ARNI-PVAUpdated Apr 8, 2026

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

An observational study in Heart Failure With Reduced Ejection Fraction, sponsored by University of Leipzig. Completed at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by University of Leipzig · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
117
Ages
18 Years and older
Sex
All
01

Study 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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Conditions studied

  • Heart Failure With Reduced Ejection Fraction
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In context

Lead sponsor

University of Leipzig is the lead sponsor of 147 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with symptomatic heart failure (NYHA functional class II to IV) and reduced ejection fraction (LVEF≤40%) with clinical indication for therapy with Sacubitril-Valsartan

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
117 participants (actual)
Target follow-up
12 Months
Patient registry
Yes

Interventions

  • DrugSacubitril-Valsartan

    Observational study during the clinically indicated treatment

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What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

Other outcomes

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

    * 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

    Time frame: 3, 6 and 12 months

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Study locations

2 sites
  • University of Leipzig
    Leipzig, Saxony 04103, Germany
  • Kardiopraxis Schirmer
    Kaiserslautern, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04498780
Lead sponsor
University of Leipzig
Responsible party
Daniel Lavall (Dr. med. Daniel Lavall, University of Leipzig) — Principal investigator
First posted
Aug 4, 2020
Start date
Jul 21, 2020
Primary completion
Dec 31, 2025
Completion
Apr 8, 2026
Last update
Apr 8, 2026

Study contacts

Daniel Lavall, MD
principal investigator · University of Leipzig

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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