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

Sponsor
Kafrelsheikh University
Study ID
NCT07610174
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 2, 2025
Status verified
May 2026
Primary completion
Apr 29, 2026
Completion
Apr 29, 2026

Study Design

Enrollment
160 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Combination Therapy Arm
    Patients receive subcutaneous (s.c.) semaglutide escalated according to standard clinical protocol, initiated at a dose of 0.25 mg once weekly for 4 weeks, followed by a stepwise dose escalation every 4 weeks to 0.5 mg, then 1.0 mg if tolerated, administered in addition to a stable baseline regimen of dapagliflozin (10 mg once daily).
  • Active Comparator: Monotherapy Control Arm
    Patients continue to receive standard-of-care dapagliflozin monotherapy (10 mg once daily).

Primary Outcome Measure

Change from Baseline in Left Ventricular Global Longitudinal Strain (LV-GLS) assessed by echocardiography [ Time Frame: Baseline and 12 weeks ]

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