Dapagliflozin and Inflammation Around Heart Arteries in Stage 4 Cardiovascular-Kidney-Metabolic Syndrome
Tests dapagliflozin for coronary inflammation in adults with advanced cardiovascular-kidney-metabolic syndrome.
Plain-language title generated from the registry record
Registry title: CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
Key facts
- Where
- Shenyang, ChinaSee the site
- Phase
- Phase 4
Where in China
- General Hospital of Northern Theater CommandShenyang, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shenyang Northern Hospital
- Trial code
- NCT07351643
- Record updated
- 30 October 2026
- Original description
The aim of this clinical trial is to investigate whether dapagliflozin (a sodium-glucose cotransporter 2 inhibitor, SGLT2i) can reduce levels of coronary inflammation in patients with stage 4 CKM syndrome.Read full original descriptionShow less
Assessment of the Effects of SGLT2 Inhibitors on Pericoronary Fat in Patients With Stage 4 CKM Syndrome Using Photon-counting CT
The aim of this clinical trial is to investigate whether dapagliflozin (a sodium-glucose cotransporter 2 inhibitor, SGLT2i) can reduce levels of coronary inflammation in patients with stage 4 CKM syndrome.
Coronary inflammation will be measured using the fat attenuation index (FAI), a marker derived from coronary CT angiography (CCTA) that quantifies inflammation in the fat tissue surrounding heart arteries.
The main questions it aims to answer are
* Does dapagliflozin lower coronary artery inflammation as measured by FAI? * Does dapagliflozin slow the progression of coronary plaques?
Researchers will compare participants who take dapagliflozin 10 mg daily plus standard therapy to those who receive standard therapy alone for 6 months.
Participants will:
* Undergo percutaneous coronary intervention (PCI) for ACS * Have a baseline CCTA scan at 1 month after PCI, at which point they will be randomly assigned to receive dapagliflozin or standard care alone. * Have a follow-up CCTA scan at 6 months after randomisation. * Receive follow-up phone calls at 3 and 6 months after randomisation
Inclusion: Aged ≥ 18 years, irrespective of gender; Meeting the diagnostic criteria for stage 4 CKM syndrome; Able to cooperate with photon-counting CT examination during the index hospitalisation, with no contraindications to the examination; Signed informed consent form.
Exclusion: Receiving SGLT2 inhibitor therapy within 4 weeks prior to enrolment; History of recurrent urogenital tract infections; History of allergy or intolerance to SGLT2 inhibitors; Other conditions deemed inappropriate for enrolment by the investigator(s); Severe chronic kidney disease (eGFR < 30 mL/min/1.73 m²); Severe hepatic dysfunction (Child-Pugh class C); Pregnant or lactating women; Systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 60 mmHg; Participation in other interventional clinical trials.