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

NCT07417215 | Not Yet Recruiting Phase 4

• 1 other identifier: 01/25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hemodialysis; Heart Failure With Preserved Ejection Fraction (HFPEF); Sacubitril/Valsartan

Outcome Measures

Primary Outcomes (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.

  2 months

Secondary Outcomes (3)

• Change in left ventricular global longitudinal strain (LV GLS)

  2 months

• Change in E/e' ratio

  2 months

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

  2 months

Study Arms (2)

Experimental - Sacubitril/valsartan

EXPERIMENTAL

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

Drug: Sacubitril / Valsartan

Standard Therapy for hemodialysis patients

NO INTERVENTION

30 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)

Interventions

Sacubitril / Valsartan DRUG

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

Experimental - Sacubitril/valsartan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University Clinical Hospital Mostar: lead

Study Sites (1)

University Clinical Hospital Mostar

Mostar, 88000, Bosnia and Herzegovina

Location

Related Publications (2)

• 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.

  PMID: 28395286 BACKGROUND

• 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.

  PMID: 36440034 BACKGROUND

MeSH Terms

Interventions

sacubitril and valsartan sodium hydrate drug combination

Central Study Contacts

Ivan Zeljko, M. D.

CONTACT

+38763229939; ivan.zeljko9@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M. D. ; Principal Investigator

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 18, 2026
• Study Start: January 30, 2026
• Primary Completion: April 10, 2026
• Study Completion: April 10, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)