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

NCT07610174 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-05-29

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Kafrelsheikh University

    lead OTHER

Principal Investigators

  • Reda B Bastawisy, MD (Professor) · Faculty of medicine, Kafrelshiekh university

  • Mohamed K Salama, MD (Assistant professor) · Faculty of medicine, Kafrelshiekh university

  • Khaled E Hamada, MD (cardiology) · Faculty of medicine, Kafrelshiekh university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-02
Primary Completion
2026-04-29
Completion
2026-04-29

Countries

  • Egypt

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07610174 on ClinicalTrials.gov