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COMPLETED
NCT07610174
PHASE2

Effects of Dapagliflozin, Semaglutide, and Their Combination in Heart Failure Patients With Prosthetic Heart Valves

Sponsor: Kafrelsheikh University

View on ClinicalTrials.gov

Summary

This study evaluates whether adding a medication called semaglutide to an existing treatment of dapagliflozin provides better outcomes for patients with heart failure who have previously undergone surgical heart valve replacement. Dapagliflozin is already a standard treatment for managing heart failure symptoms. However, many heart failure patients-especially those who have had surgical prosthetic valve replacements-continue to experience persistent symptoms, fluid retention, and a decline in their quality of life. This trial aims to investigate whether combining dapagliflozin with semaglutide (a medication widely used for metabolic health and weight management) can safely offer additional clinical benefits. Participants in this study are divided into two groups: Group 1 (Combination Therapy): Receives semaglutide added to their standard dapagliflozin routine. Group 2 (Monotherapy Control): Continues receiving dapagliflozin alone. Researchers will monitor both groups over a set treatment period to compare changes in heart function, symptom management, fluid control, and overall quality of life to see if the combination approach is more effective than standard treatment.

Official title: A Prospective, Randomized, Open-Label, Blinded-Endpoint, Parallel-Group, Phase IIb Proof-of-Concept Clinical Trial of Semaglutide Added to Dapagliflozin Versus Dapagliflozin Monotherapy in Patients With Heart Failure and Previous Surgical Prosthetic Valve Replacement

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2025-06-02

Completion Date

2026-04-29

Last Updated

2026-05-29

Healthy Volunteers

No

Interventions

DRUG

semaglutide

Subcutaneous (s.c.) semaglutide initiated at a dose of 0.25 mg once weekly for 4 weeks, followed by standard clinical titration (escalating every 4 weeks through 0.5 mg, then 1.0 mg, up to the maximum tolerated maintenance dose) for the duration of the study period.

DRUG

Dapagliflozin (10mg Tab)

Sodium-glucose cotransporter 2 (SGLT2) inhibitor administered orally at a stable, standard-of-care dose of 10 mg once daily.

Locations (1)

Kafrelsheikh univeristy hospital, Faculty of medicine, Kafrelsheikh univeristy

Kafr ash Shaykh, Kafrelsheikh Governrate, Egypt