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

Phase 3

Active, not recruiting

• Conditions: ST-segment Elevation Myocardial Infarction (STEMI); Diabetes Mellitus; Myocardial Fibrosis; Heart Failure
• Interventions: Drug: Placebo; Drug: Dapagliflozin

• Registration Number: NCT06619600
• Lead Sponsor: Hospital Clinic of Barcelona

Brief 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 wh...

Detailed Description

The DAPA-STEMI trial is a clinical research study designed to investigate whether dapagliflozin, a medication known as a sodium-glucose cotransporter 2 inhibitor (SGLT2i), can reduce the extent of heart muscle damage and improve heart function in patients who have experienced a heart attack. Specifically, the study focuses on patients who have had a type of ...

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2021-05-30
• Status Verified: 2024-09
• Study First Submitted: 2024-09-27
• Study First Submitted QC: 2024-09-27
• Last Update Submitted: 2024-09-27
• Study First Posted: 2024-09-30
• Last Update Posted: 2024-09-30
• Primary Completion: 2024-10-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 54

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matched placebo qd
Dapagliflozin	Dapagliflozin	Dapagliflozin 10 mg qd

Primary Outcome Measures

Name	Time	Method
Extracellular volume (ECV, %)	6 months	To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the extracellular volume (ECV) of the remote myocardium between the 6-month and baseline follow- up, evaluated by cardiac magnetic resonance (ΔECV dapagliflozin group versus ΔECV placebo group; \[ΔECV = ECV 6-month - ECV baseline\]).

Secondary Outcome Measures

Name	Time	Method
Serum levels of C-terminal propeptide of type I procollagen (PICP)	6 months	To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of C-terminal propeptide of type I procollagen (PICP) between the 6-month and baseline follow- up, evaluated by cardiac magnetic resonance (ΔPICP dapagliflozin group versus ΔPICP placebo group; \[ΔPICP = PICP 6-month - PICP baseline\]).
N-terminal propeptide of type III (PIIINP)	6 months	To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of N-terminal propeptide of type III (PIIINP) between the 6-month and baseline follow- up, evaluated by cardiac magnetic resonance (ΔPIIINP dapagliflozin group versus ΔPIIINP placebo group; \[ΔPIIINP = PIIINP 6-month - PIIINP baseline\]).
Galectin-3 procollagen (Gal-3)	6 months	To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of galectin-3 procollagen (Gal-3) between the 6-month and baseline follow- up, evaluated by cardiac magnetic resonance (ΔGal-3 dapagliflozin group versus ΔGal-3 placebo group; \[ΔGal-3 = Gal-3 6-month - Gal-3 baseline\]).
High-Sensitivity cardiac Troponin I (hs-cTnI)	6 months	To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of High-Sensitivity cardiac Troponin I (hs-cTnI) between the 6-month and baseline follow- up, evaluated by cardiac magnetic resonance (hs-cTnI dapagliflozin group versus hs-cTnI placebo group; \[Δhs-cTnI = hs-cTnI 6-month - hs-cTnI baseline\]).

Trial Locations

Locations (2)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Catalonia, Spain

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Catalonia, Spain