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Clinical Trials in Spain / NCT06619600
Active, not recruiting Phase 3

Effect of Dapagliflozin in Myocardial Fibrosis and Ventricular Function in Patients With a ST-segment Elevation Myocardial Infarction

NCT06619600 · tracked via the Priya Life Science Spain tracker
Phase
Phase 3
Started
2021-05-30
Last updated
2025-02-19

Condition(s) studied

ST-segment Elevation Myocardial Infarction (STEMI)Diabetes MellitusHeart FailureMyocardial Fibrosis

Investigational drug(s) / intervention(s)

Dapagliflozin →Placebo

Dapagliflozin: Dapagliflozin 10 mg qd

Placebo: Matched placebo qd

Study summary

The DAPA-STEMI trial investigates whether dapagliflozin, a sodium-glucose cotransporter 2 inhibitor (SGLT2i), reduces heart muscle scarring (fibrosis) and improves heart function after a ST-segment elevation myocardial infarction (STEMI). The trial will use cardiac MRI to measure changes in heart structure and function over six months. Patients aged 30-85 who have had a recent STEMI will receive either dapagliflozin or a placebo. The study aims to provide mechanistic insights into heart failure prevention after heart attacks.

Eligibility

Sex
ALL
Min age
30 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients between 30 - 85 years of age. 2. Patients with first infarction with ST-segment elevation documented in an ambulance or a cardiac catheterization laboratory (ST-segment elevation ≥2 mm in at least two contiguous leads) less than 12 hours after onset of symptoms that last ≥ 20 min, that is treated with primary percutaneous cardiac intervention. 3. The target lesion must be a de novo lesion located in a native vessel. 4. The patient understands and accepts the clinical monitoring and cardiac magnetic resonance. 5. The patient has to be hemodynamically stable (Killip classification 1) at the time of the initial cardiac magnetic resonance. 6. A left ventricular ejection fraction ≤50% in the baseline echocardiogram. Exclusion Criteria: 1. Pregnant or lactating women. 2. Type 1 diabetes. 3. Previous treatment with SGLT2i. 4. Severe liver disease (Child-Pugh C). 5. Kidney disease defined as stage III or worse (eGFR less than 45 ml/min). 6. Systolic blood pressure less than 90 mmHg at the screening visit. 7. Malignancy (receiving active treatment) or other life-threatening diseases. 8. Any contraindication to cardiac MRI (e.g., claustrophobia, metal implants, penetrating eye injury, or exposure to metal fragments in the eye that require medical attention). 9. Previous complicated urinary tract infection in men or repeated urinary infection in women. 10. Patients treated with fibrinolytic therapy.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Hospital de la Santa Creu i Sant Pau Barcelona Catalonia
Hospital Clinic of Barcelona Barcelona Catalonia

On this site

📄 Farxiga (dapagliflozin) drug profile →

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06619600 on ClinicalTrials.gov ↗ ← All trials in Spain