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Heart Failure With Preserved Ejection Fraction (HFPEF)Phase 4NCT07417215

The Effect of Sacubitril and Valsartan on Heart Function in Chronic Hemodialysis Patients With HFpEF

A Phase 4 study testing Sacubitril / Valsartan in people with Heart Failure With Preserved Ejection Fraction (HFPEF) and Hemodialysis, run by University Clinical Hospital Mostar at 1 site in Bosnia and Herzegovina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Heart failure is the most common cause of death of patients on chronic hemodialysis treatment, and to date there is no effective therapy for the treatment of this comorbidity in this group of patients. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sacubitril / Valsartan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteBosnia and Herzegovina
Study dates
30 Jan 2026to 10 May 2026
Phase
Phase 4
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

Inclusion Criteria: patients on chronic hemodialysis treatment (minimum 1 year); confirmed diagnosis of HFpEF; systolic arterial pressure >100 mmHg.

-

Exclusion Criteria: patients not on chronic hemodialysis treatment; patients with unconfirmed diagnosis of HFpEF; patients with systolic blood pressure <100 mmHg; patients unwilling to participate in the study;

-

Trial locations and contacts

1 site in 1 country.

Bosnia and Herzegovina1 site

  • University Clinical Hospital Mostar

    Mostar, 88000

Other trials in Bosnia and Herzegovina

About this study

Heart failure is the most common cause of death of patients on chronic hemodialysis treatment, and to date there is no effective therapy for the treatment of this comorbidity in this group of patients. The most common form of heart failure in these groups of patients is heart failure with preserved ejection fraction (HFpEF). As a new therapy for heart failure, a new group of drugs called angiotensin receptor and neprilysin inhibitors (ARNI) has been imposed, whose representative is the drug sacubitril/valsartan. The therapy has been shown to be superior to any other therapy to date for the treatment of heart failure with reduced ejection fraction (HFrEF) and has been included in European and American guidelines for the treatment of patients with HFrEF. Since 2022, the drug has been approved in the USA for the treatment of patients with HFpEF, while in Europe it is still not approved for this indication.

Currently, the drug is not approved for patients on chronic hemodialysis anywhere in the world, and its effect on this group of patients is unknown. There are very few studies examining the safety and efficacy of sacubitril/valsartan in chronic hemodialysis patients with HFpEF. Precisely because of this, the aim of this study is to determine the effectiveness of this drug in these groups of patients. I will conduct the research as a randomized controlled trial (single blind research) where the subjects will be patients on chronic hemodialysis treatment who have proven HFpEF. HFpEF is proven by the HFA-PEFF scale. The patients will be divided into two groups - the test group and the control group (30 patients in each group). The input variables will be patients on chronic hemodialysis treatment (whose hemodialysis treatment lasts at least one year); patients with heart failure with preserved ejection fraction; height; weight. Output variables will be heart ultrasound parameters and laboratory findings (NTproBNP, hs troponin, aldosterone, renin). The aim of the study is to determine the effect of sacubitril/valsartan on ultrasound parameters and on cardiovascular and other biomarkers in patients on chronic hemodialysis treatment with HFpEF.

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

    30 patients on chronic hemodialysis with proven heart failure with preserved ejection fraction will receive sacubitril/valsartan

Study groups in NCT07417215
Study groupRoleWhat they receive
Experimental - Sacubitril/valsartanExperimental30 patients on chronic hemodialysis with proven heart failure with preserved ejection fraction will receive sacubitril/valsartan
Receives: Drug: Sacubitril / Valsartan
Standard Therapy for hemodialysis patientsNo intervention30 patients on chronic hemodialysis who have proven heart failure with preserved ejection fraction will not receive any other medication (they will receive the gold standard)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in left atrial volume index (LAVI)

    Change in left atrial volume index (LAVI), measured by transthoracic echocardiography using the biplane area-length method and indexed to body surface area (mL/m²).

    LAVI will be calculated according to current echocardiographic guidelines. The outcome is defined as the absolute change in LAVI from baseline to 2 months following initiation of sacubitril/valsartan therapy in the experimental group and during standard therapy in the control group.

    Measured: 2 months

Secondary outcomes (3)

  1. Change in left ventricular global longitudinal strain (LV GLS)

    Change in left ventricular global longitudinal strain (LV GLS), assessed by two-dimensional speckle-tracking echocardiography. LV GLS will be measured from standard apical views and expressed as a percentage (%). The outcome is defined as the absolute change in LV GLS from baseline to 2 months following initiation of sacubitril/valsartan therapy in the experimental group and during standard therapy in the control group.

    Measured: 2 months

  2. Change in E/e' ratio

    Change in left ventricular filling pressure estimated by the E/e' ratio, measured by transthoracic echocardiography. Early diastolic transmitral flow velocity (E wave) will be obtained using pulsed-wave Doppler at the mitral valve leaflet tips, and early diastolic mitral annular velocity (e') will be measured by tissue Doppler imaging at the septal mitral annulus. The outcome is defined as the absolute change in E/e' ratio from baseline to 2 months following initiation of sacubitril/valsartan therapy in the experimental group and during standard therapy in the control group.

    Measured: 2 months

  3. Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)

    Change in plasma concentration of N-terminal pro-B-type natriuretic peptide (NT-proBNP), measured using a standardized immunoassay and expressed in pg/mL. The outcome is defined as the absolute change in NT-proBNP levels from baseline to 2 months following initiation of sacubitril/valsartan therapy in the experimental group and during standard therapy in the control group.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2026
  2. Study start30 Jan 2026
  3. Primary completion10 May 2026
  4. Study completion10 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07417215
Sponsor's protocol ID
01/25
Status last verified
May 2026
First submitted
26 Jan 2026
Last updated
20 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Antlanger M, Aschauer S, Kopecky C, Hecking M, Kovarik JJ, Werzowa J, Mascherbauer J, Genser B, Saemann MD, Bonderman D. Heart Failure with Preserved and Reduced Ejection Fraction in Hemodialysis Patients: Prevalence, Disease Prediction and Prognosis. Kidney Blood Press Res. 2017;42(1):165-176. doi: 10.1159/000473868. Epub 2017 Apr 11.

    PubMed 28395286

  • Guo Y, Ren M, Wang T, Wang Y, Pu T, Li X, Yu L, Wang L, Liu P, Tang L. Effects of sacubitril/valsartan in ESRD patients undergoing hemodialysis with HFpEF. Front Cardiovasc Med. 2022 Nov 9;9:955780. doi: 10.3389/fcvm.2022.955780. eCollection 2022.

    PubMed 36440034

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sacubitril / Valsartan in people with Heart Failure With Preserved Ejection Fraction (HFPEF) and Hemodialysis, run by University Clinical Hospital Mostar at 1 site in Bosnia and Herzegovina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bosnia and Herzegovina. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change in left atrial volume index (LAVI) (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07417215, which also lists 2 linked publications.

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 20 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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