Heart Failure With Reduced Ejection FractionARNI-PVANCT04498780
Hemodynamic Effects of ARNI on Noninvasive Pressure-volume Analysis in Patients With Chronic Heart Failure
An observational study of Heart Failure With Reduced Ejection Fraction, run by University of Leipzig at 2 sites in Germany.
Trial summary
Sacubitril-Valsartan reduced heart failure hospitalizations and cardiovascular mortality compared to enelapril in chronic heart failure. Furthermore, quality of life is improved. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Sacubitril-Valsartan
- How many people
- 117 participants
- Where
- 2 sitesGermany
- Study dates
- 21 Jul 2020to 8 Apr 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Symptomatic heart failure (NYHA functional class II to IV)
- Reduced LV ejection fraction (≤ 40%)
- Clinical indication for therapy with Sacubitril-Valsartan
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Kardiopraxis Schirmer
Kaiserslautern
University of Leipzig
Leipzig, Saxony, 04103
About this study
Official title: 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.
- Being tested
- Sacubitril-Valsartan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril-ValsartanDrug
Observational study during the clinically indicated treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular contractility, afterload and ventricular-arterial coupling
Change of end-systolic elastance (Ees), arterial elastance (Ea) and ventricular-arterial coupling (Ea/Ees)
Measured: 6 months
Secondary outcomes (2)
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
Measured: 3, 6 and 12 months
Left ventricular contractility, afterload and ventricular-arterial coupling
Change of end-systolic elastance (Ees), arterial elastance (Ea) and ventricular-arterial coupling (Ea/Ees)
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start21 Jul 2020
- Primary completion31 Dec 2025
- Study completion8 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Lavall, University of Leipzig
- Investigators
- Daniel Lavall, MD, Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498780
- Sponsor's protocol ID
- DL-L-20005_V1.4
- Acronym
- ARNI-PVA
- Status last verified
- May 2023
- First submitted
- 29 Jul 2020
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Angiotensin Receptor Neprilysin Inhibition on Noninvasive Pressure-volume Analysis in Patients With Heart Failure With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT04498780
- Acronym / sponsor ID
- ARNI-PVA / DL-L-20005_V1.4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 8 Apr 2026 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Symptomatic heart failure (NYHA functional class II to IV)
- Reduced LV ejection fraction (≤ 40%)
- Clinical indication for therapy with Sacubitril-Valsartan
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacubitril-ValsartanObservational study during the clinically indicated treatment | Drug | – |
Primary outcome
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)
2 secondary outcomes
Systolic and diastolic LV function, symptom status and biomarkers
Time frame: 3, 6 and 12 months
Left ventricular contractility, afterload and ventricular-arterial coupling
Time frame: 3 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Lavall, MD principal investigator
University of Leipzig
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Reduced Ejection Fraction, run by University of Leipzig at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular contractility, afterload and ventricular-arterial coupling (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.