Heart FailurePhase 2SYNCARDIA-HFNCT07610174
Effects of Dapagliflozin, Semaglutide, and Their Combination in Heart Failure Patients With Prosthetic Heart Valves
A Phase 2 study testing semaglutide and Dapagliflozin (10mg Tab) in people with Heart Failure and Heart Valve Prosthesis, run by Kafrelsheikh University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Valve Prosthesis
- What is being tested?
- semaglutide and Dapagliflozin (10mg Tab)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jun 2025to 29 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kafrelsheikh univeristy hospital, Faculty of medicine, Kafrelsheikh univeristy
Kafr ash Shaykh, Kafrelsheikh Governrate, 33511
About this study
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
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.
Read more
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.
Read the detailed description
This is a single-center, prospective, randomized, open-label, blinded-endpoint (PROBE), parallel-group, Phase IIb proof-of-concept clinical trial conducted at Kafrelsheikh University Hospital. The study evaluates the clinical efficacy, safety, and tolerability of combining the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide with the sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin, compared against dapagliflozin monotherapy, in patients presenting with heart failure (HF) who have a history of surgical prosthetic heart valve replacement.
A total of 160 eligible patients are randomized in a strict 1:1 allocation ratio to one of two parallel treatment arms:
Combination Therapy Arm: Patients receive oral semaglutide escalated according to standard clinical protocol, administered in addition to a stable baseline regimen of dapagliflozin (10 mg once daily).
Monotherapy Control Arm: Patients continue to receive standard-of-care dapagliflozin monotherapy (10 mg once daily).
The primary objective is to determine if dual metabolic pathway modulation via combined SGLT2 inhibition and GLP-1 receptor agonism provides superior optimization of cardiovascular outcomes over SGLT2 inhibition alone. Key secondary and surrogate clinical outcomes assessed across the treatment duration include changes in New York Heart Association (NYHA) functional class, evaluation of fluid retention and diuretic requirements, echocardiographic parameters evaluating cardiac structure and function, and standardized quality-of-life assessment scores. Safety and tolerability profiles-including adverse event rates and systemic hemodynamic responses-will be rigorously monitored across both treatment cohorts.
- Conditions
- Heart Failure, Heart Valve Prosthesis
- Being tested
- semaglutide, Dapagliflozin (10mg Tab)
- Keywords
- Heart failure, Prosthetic heart valve, Semaglutide, Dapagliflozin, SGLT2 inhibitors, GLP-1 receptor agonists, Valve surgery
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutideDrug
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 group | Role | What they receive |
|---|---|---|
| Combination Therapy Arm | Experimental | 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). Receives: Drug: semaglutide; Drug: Dapagliflozin (10mg Tab) |
| Monotherapy Control Arm | Active comparator | Patients continue to receive standard-of-care dapagliflozin monotherapy (10 mg once daily). Receives: Drug: Dapagliflozin (10mg Tab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Left Ventricular Global Longitudinal Strain (LV-GLS) assessed by echocardiography
Left ventricular global longitudinal strain (LV-GLS) will be calculated as the average peak systolic strain using a 17-segment model derived from apical two-, three-, and four-chamber views. All studies are analyzed offline using validated software by experienced echocardiographers blinded to treatment allocation.
Unit of Measure: Percentage (%), Strain is expressed as a percentage of deformation, typically a negative value where a more negative number indicates better systolic function.
Measured: Baseline and 12 weeks
Secondary outcomes (4)
Change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels.
NT-proBNP is a well-established blood biomarker used to monitor myocardial wall stress and the severity of heart failure. Blood samples are drawn to measure the mean change in NT-proBNP levels (measured in pg/mL) from randomization baseline to the final follow-up.
Measured: Baseline and 12 weeks.
Change from baseline in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS).
The KCCQ-CSS is a patient-reported health status instrument specifically designed to measure the symptoms and physical limitations associated with heart failure. Scores range from 0 to 100, where lower scores reflect more severe symptoms/limitations and higher scores indicate better health status. This measure evaluates the efficacy of adding subcutaneous semaglutide to dapagliflozin compared to dapagliflozin alone by calculating the mean change in KCCQ-CSS from the randomization baseline to the final follow-up.
Measured: Baseline and 12 weeks.
Change from baseline in Six-Minute Walk Test (6MWT) distance.
The 6MWT evaluates objective functional capacity and exercise tolerance in heart failure patients. The test measures the maximum distance (in meters) a participant can quickly walk on a flat, hard surface in a period of 6 minutes. This endpoint calculates the mean change in walked distance from baseline to the end of the study.
Measured: Baseline and 12 weeks.
Change from Baseline in E/e' Ratio assessed by echocardiography
Calculated using transmitral Doppler peak early filling velocity (E) in cm/s and tissue Doppler early diastolic mitral annular velocity (e') in cm/s to evaluate left ventricular diastolic filling pressure.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start2 Jun 2025
- Primary completion29 Apr 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, prospective, randomized, open-label, parallel-group trial. A total of 160 eligible patients are randomized in a strict 1:1 allocation ratio into two parallel groups: the Combination Therapy Arm (receiving oral semaglutide added to a stable baseline of 10 mg/day dapagliflozin) and the Monotherapy Control Arm (continuing on 10 mg/day dapagliflozin alone). Participants remain in their assigned treatment arm for the entire duration of the study period to compare the efficacy and safety outcomes between the two distinct therapeutic approaches.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsen Abdelaziz Mohsen Morshedi, Kafrelsheikh University
- Investigators
- Reda B Bastawisy, MD (Professor), Study chair, Faculty of medicine, Kafrelshiekh universityMohamed K Salama, MD (Assistant professor), Study chair, Faculty of medicine, Kafrelshiekh universityKhaled E Hamada, MD (cardiology), Study chair, Faculty of medicine, Kafrelshiekh university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610174
- Sponsor's protocol ID
- KFSIRB200-648
- Acronym
- SYNCARDIA-HF
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including baseline characteristics, outcome measures, and relevant clinical variables) will be made available upon reasonable request after publication of the study results.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07610174
- Acronym / sponsor ID
- SYNCARDIA-HF / KFSIRB200-648
- Conditions
- Heart Failure, Heart Valve Prosthesis
- Keywords
- Heart failure, Prosthetic heart valve, Semaglutide, Dapagliflozin, SGLT2 inhibitors, GLP-1 receptor agonists, Valve surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-center, prospective, randomized, open-label, blinded-endpoint (PROBE), parallel-group, Phase IIb proof-of-concept clinical trial conducted at Kafrelsheikh University Hospital. The study evaluates the clinical efficacy, safety, and tolerability of combining the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide with the sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin, compared against dapagliflozin monotherapy, in patients presenting with heart failure (HF) who have a history of surgical prosthetic heart valve replacement.
A total of 160 eligible patients are randomized in a strict 1:1 allocation ratio to one of two parallel treatment arms:
Combination Therapy Arm: Patients receive oral semaglutide escalated according to standard clinical protocol, administered in addition to a stable baseline regimen of dapagliflozin (10 mg once daily).
Monotherapy Control Arm: Patients continue to receive standard-of-care dapagliflozin monotherapy (10 mg once daily).
The primary objective is to determine if dual metabolic pathway modulation via combined SGLT2 inhibition and GLP-1 receptor agonism provides superior optimization of cardiovascular outcomes over SGLT2 inhibition alone. Key secondary and surrogate clinical outcomes assessed across the treatment duration include changes in New York Heart Association (NYHA) functional class, evaluation of fluid retention and diuretic requirements, echocardiographic parameters evaluating cardiac structure and function, and standardized quality-of-life assessment scores. Safety and tolerability profiles-including adverse event rates and systemic hemodynamic responses-will be rigorously monitored across both treatment cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-center, prospective, randomized, open-label, parallel-group trial. A total of 160 eligible patients are randomized in a strict 1:1 allocation ratio into two parallel groups: the Combination Therapy Arm (receiving oral semaglutide added to a stable baseline of 10 mg/day dapagliflozin) and the Monotherapy Control Arm (continuing on 10 mg/day dapagliflozin alone). Participants remain in their assigned treatment arm for the entire duration of the study period to compare the efficacy and safety outcomes between the two distinct therapeutic approaches.
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy Arm | Experimental | Drug: semaglutide, Drug: Dapagliflozin (10mg Tab)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). |
| Monotherapy Control Arm | Active comparator | Drug: Dapagliflozin (10mg Tab)Patients continue to receive standard-of-care dapagliflozin monotherapy (10 mg once daily). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semaglutideSubcutaneous (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 | Combination Therapy Arm |
| Dapagliflozin (10mg Tab)Sodium-glucose cotransporter 2 (SGLT2) inhibitor administered orally at a stable, standard-of-care dose of 10 mg once daily. | Drug | Combination Therapy Arm, Monotherapy Control Arm |
Primary outcome
Change from Baseline in Left Ventricular Global Longitudinal Strain (LV-GLS) assessed by echocardiography
Time frame: Baseline and 12 weeks
Left ventricular global longitudinal strain (LV-GLS) will be calculated as the average peak systolic strain using a 17-segment model derived from apical two-, three-, and four-chamber views. All studies are analyzed offline using validated software by experienced echocardiographers blinded to treatment allocation. Unit of Measure: Percentage (%), Strain is expressed as a percentage of deformation, typically a negative value where a more negative number indicates better systolic function.
4 secondary outcomes
Change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels.
Time frame: Baseline and 12 weeks.
Change from baseline in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS).
Time frame: Baseline and 12 weeks.
Change from baseline in Six-Minute Walk Test (6MWT) distance.
Time frame: Baseline and 12 weeks.
Change from Baseline in E/e' Ratio assessed by echocardiography
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including baseline characteristics, outcome measures, and relevant clinical variables) will be made available upon reasonable request after publication of the study results.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reda B Bastawisy, MD (Professor) study chair
Faculty of medicine, Kafrelshiekh university
Mohamed K Salama, MD (Assistant professor) study chair
Faculty of medicine, Kafrelshiekh university
Khaled E Hamada, MD (cardiology) study chair
Faculty of medicine, Kafrelshiekh university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing semaglutide and Dapagliflozin (10mg Tab) in people with Heart Failure and Heart Valve Prosthesis, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Left Ventricular Global Longitudinal Strain (LV-GLS) assessed by echocardiography (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.