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

April 7, 2026 updated by: Daniel Lavall, University of Leipzig

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

117

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Kaiserslautern, Germany
        • Kardiopraxis Schirmer
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • University of Leipzig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3, 6 and 12 months
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)
3 and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Investigators

  • Principal Investigator: Daniel Lavall, MD, University of Leipzig

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2020

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

April 8, 2026

Study Registration Dates

First Submitted

July 29, 2020

First Submitted That Met QC Criteria

July 30, 2020

First Posted (Actual)

August 4, 2020

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DL-L-20005_V1.4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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