NCT07417215

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University Clinical Hospital Mostar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
DRUG	Sacubitril / Valsartan	30 patients on chronic hemodialysis with proven heart failure with preserved ejection fraction will receive sacubitril/valsartan

Timeline

• Start date: 2026-01-30
• Primary completion: 2026-04-10
• Completion: 2026-04-10
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: Bosnia and Herzegovina