Effects of Dapagliflozin, Semaglutide, and Their Combination in Heart Failure Patients With Prost… (NCT07610174) | Clinical Trial Compass
CompletedPhase 2
Effects of Dapagliflozin, Semaglutide, and Their Combination in Heart Failure Patients With Prosthetic Heart Valves
Egypt160 participantsStarted 2025-06-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Known hypersensitivity or allergy to semaglutide, dapagliflozin, or any of their excipients.
* Type 1 diabetes mellitus.
* Severe renal impairment (e.g., eGFR \< 25 or 30 mL/min/1.73m², depending on your exact protocol threshold) or currently requiring dialysis.
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Left Ventricular Global Longitudinal Strain (LV-GLS) assessed by echocardiography