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

NCT06619600 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: ESR-19-144892018-003105-25
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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 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.

Conditions

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

Keywords

Dapagliflozin; Myocardial Fibrosis; ST-segment Elevation Myocardial Infarction (STEMI); Cardiac Magnetic Resonance (CMR); Heart Failure

Outcome Measures

Primary Outcomes (1)

• Extracellular volume (ECV, %)

  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; \[ΔECV = ECV 6-month - ECV baseline\]).

  6 months

Secondary Outcomes (4)

• Serum levels of C-terminal propeptide of type I procollagen (PICP)

  6 months

• N-terminal propeptide of type III (PIIINP)

  6 months

• Galectin-3 procollagen (Gal-3)

  6 months

• High-Sensitivity cardiac Troponin I (hs-cTnI)

  6 months

Other Outcomes (9)

• N-terminal pro-brain natriuretic peptide (NT-proBNP)

  6 months

• Soluble suppression of tumorigenicity 2 (sST2)

  6 months

• Indexed ventricular mass of the left ventricle (LVMI, g/m^2)

  6 months

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Dapagliflozin 10 mg qd

Drug: Dapagliflozin

Placebo

PLACEBO COMPARATOR

Matched placebo qd

Drug: Placebo

Interventions

Dapagliflozin DRUG

Dapagliflozin 10 mg qd

Dapagliflozin

Placebo DRUG

Matched placebo qd

Placebo

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 30 - 85 years of age.
• 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.
• The target lesion must be a de novo lesion located in a native vessel.
• The patient understands and accepts the clinical monitoring and cardiac magnetic resonance.
• The patient has to be hemodynamically stable (Killip classification 1) at the time of the initial cardiac magnetic resonance.
• A left ventricular ejection fraction ≤50% in the baseline echocardiogram.

You may not qualify if:

• Pregnant or lactating women.
• Type 1 diabetes.
• Previous treatment with SGLT2i.
• Severe liver disease (Child-Pugh C).
• Kidney disease defined as stage III or worse (eGFR less than 45 ml/min).
• Systolic blood pressure less than 90 mmHg at the screening visit.
• Malignancy (receiving active treatment) or other life-threatening diseases.
• 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).
• Previous complicated urinary tract infection in men or repeated urinary infection in women.
• Patients treated with fibrinolytic therapy.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (2)

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

Location

Hospital Clinic of Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Related Publications (3)

• Perea RJ, Morales-Ruiz M, Ortiz-Perez JT, Bosch X, Andreu D, Borras R, Acosta J, Penela D, Prat-Gonzalez S, de Caralt TM, Martinez M, Morales-Romero B, Lasalvia L, Donnelly J, Jimenez W, Mira A, Mont L, Berruezo A. Utility of galectin-3 in predicting post-infarct remodeling after acute myocardial infarction based on extracellular volume fraction mapping. Int J Cardiol. 2016 Nov 15;223:458-464. doi: 10.1016/j.ijcard.2016.08.070. Epub 2016 Aug 8.

  PMID: 27544605 BACKGROUND

• Ortega-Paz L, Cristobal H, Ortiz-Perez JT, Garcia de Frutos P, Mendieta G, Sandoval E, Rodriguez JJ, Ortega E, Garcia-Alvarez A, Brugaletta S, Sabate M, Dantas AP. Direct actions of dapagliflozin and interactions with LCZ696 and spironolactone on cardiac fibroblasts of patients with heart failure and reduced ejection fraction. ESC Heart Fail. 2023 Feb;10(1):453-464. doi: 10.1002/ehf2.14186. Epub 2022 Oct 27.

  PMID: 36303443 BACKGROUND

• Ortega-Paz L, Laudani C, Sionis A, Vidal-Cales P, Arevalos V, Andrea R, Morr CI, De Diego O, Ortega E, Jimenez-Trinidad FR, Dantas AP, Angiolillo DJ, Sabate M, Ortiz-Perez JT, Brugaletta S. Effect of DAPAgliflozin on Myocardial Fibrosis and Ventricular Function in Patients with ST-Segment Elevation Myocardial Infarction-DAPA-STEMI Trial. J Cardiovasc Dev Dis. 2025 Jun 11;12(6):220. doi: 10.3390/jcdd12060220.

  PMID: 40558655 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Diabetes Mellitus; Heart Failure

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Luis Ortega, MD, PhD

  Division of Cardiology, University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, USA.

  PRINCIPAL INVESTIGATOR

• Salvatore Brugaletta, MD, PhD

  Hospital Clínic, Cardiovascular Clinic Institute, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: May 30, 2021
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: February 19, 2025

Record last verified: 2024-09

Locations

ES (2)