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

Hospital Clinic of Barcelona

Status and phase: Active, not recruiting; Phase 3

Conditions: Diabetes Mellitus; ST-segment Elevation Myocardial Infarction (STEMI); Myocardial Fibrosis; Heart Failure

Treatments: Drug: Placebo; Drug: Dapagliflozin

Study type: Interventional

Funder types: Other

Identifiers

NCT06619600

ESR-19-14489

2018-003105-25 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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 heart attack known as a ST-segment elevation myocardial infarction (STEMI), which is a serious condition that often leads to long-term heart damage and heart failure.

The study aims to answer whether treatment with dapagliflozin can reduce the amount of scarring (fibrosis) that develops in the heart after a heart attack, and whether this reduction in scarring improves the overall function of the heart. Scarring in the heart can lead to stiffening of the heart muscle, which affects its ability to pump blood effectively and can result in heart failure. By using advanced imaging techniques, such as cardiac magnetic resonance imaging (MRI), the study will measure changes in the heart's structure and function over time.

The primary question the study seeks to answer is whether dapagliflozin can decrease the amount of heart muscle scarring (fibrosis) and improve heart function when compared to a placebo (an inactive treatment). The study will also examine whether dapagliflozin affects other important heart health markers, such as blood levels of proteins that indicate heart muscle damage and the overall size and function of the heart chambers.

The study will enroll patients aged 30 to 85 who have recently experienced a STEMI and undergone successful treatment to open the blocked artery. Participants will be randomly assigned to receive either dapagliflozin or a placebo for six months, and their heart function and scarring will be monitored through imaging and blood tests during that time.

The results of this study may provide important insights into new ways to protect the heart after a heart attack and prevent the development of heart failure, offering potential benefits to a wide range of patients who experience heart attacks.

Enrollment: 54 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups, including a placebo group

Dapagliflozin

Experimental group

Description:

Dapagliflozin 10 mg qd

Treatment:

Drug: Dapagliflozin

Placebo

Placebo Comparator group

Description:

Matched placebo qd

Treatment:

Drug: Placebo