NCT07610174CompletedPhase 2
Effects of Dapagliflozin, Semaglutide, and Their Combination in Heart Failure Patients With Prosthetic Heart Valves
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
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 160 (actual)
- First submitted
- 20 May 2026
- Start date
- 2 Jun 2025
- Primary completion date
- 29 Apr 2026
- Lead sponsor
- Kafrelsheikh University
- Diseases
- Heart failure
- NCT number
- NCT07610174
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 160
- From 2 Jun 2025 to the primary completion date, 29 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known hypersensitivity or allergy to semaglutide, dapagliflozin, or any of their excipients.
- Type 1 diabetes mellitus.
Lab values
- Severe renal impairment (e.g., eGFR \< 25 or 30 mL/min/1.73m², depending on your exact protocol threshold) or currently requiring dialysis.
Other
- Active pregnancy, breastfeeding, or intent to become pregnant during the 12-week study period.
- Participation in another conflicting interventional clinical trial within the past 30 days.
Who the study is looking for
- Age is at least 18 years at the time of screening.
- Confirmed diagnosis of heart failure.
- Documented history of surgical prosthetic heart valve replacement.
- Patient is currently on a stable baseline regimen of dapagliflozin (10 mg once daily).
- Patient is willing and able to provide written informed consent prior to any study-related procedures.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kafrelsheikh univeristy hospital, Faculty of medicine, Kafrelsheikh univeristy Coordinator of this site? Confirm its status | Kafr ash Shaykh | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.