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Delfa

← All trials/NCT07610174

SYNCARDIA-HF

CompletedPhase 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

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

160

Study population

Heart failure

Eligibility highlights

-

Primary endpoint

•Left Ventricular Global Longitudinal Strain (LV-GLS)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07610174
Org study IDKFSIRB200-648

Timeline

Milestones

Study start2025-06-02actual
Primary completion2026-04-29actual
Study completion2026-04-29actual
Study first posted2026-05-27actual
Last update posted2026-05-29actual

Assets

Investigational agents

Semaglutide

Who this study enrolls

Heart failure

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
3
Heart failure
2

Heart failure

2 endpoints
Secondary/protocol endpoint

Change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels.

Time frame:Baseline and 12 weeks.

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS).

Time frame:Baseline and 12 weeks.

change from baseline, improvement

Other (unclassified)

3 endpoints
Primary/protocol endpoint/low confidence

Change from Baseline in Left Ventricular Global Longitudinal Strain (LV-GLS) assessed by echocardiography

Time frame:Baseline and 12 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in Six-Minute Walk Test (6MWT) distance.

Time frame:Baseline and 12 weeks.

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in E/e' Ratio assessed by echocardiography

Time frame:Baseline and 12 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.