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ST-segment Elevation Myocardial Infarction (STEMI)Phase 3DAPA-STEMINCT06619600

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

A Phase 3 study testing Dapagliflozin in people with ST-segment Elevation Myocardial Infarction (STEMI) and Diabetes Mellitus, run by Hospital Clinic of Barcelona at 2 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 30 to 85 years
What is being tested?
Dapagliflozin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
2 sitesSpain
Study dates
30 May 2021to 31 Mar 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08025

  • Hospital Clinic of Barcelona

    Barcelona, Catalonia, 08036

Other trials in Spain

About this study

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.

Read the 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 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.

Being tested
Dapagliflozin, Placebo
Keywords
Dapagliflozin, Myocardial Fibrosis, ST-segment Elevation Myocardial Infarction (STEMI), Cardiac Magnetic Resonance (CMR), Heart Failure
Medical subject headings
ST Elevation Myocardial Infarction, Diabetes Mellitus, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DapagliflozinDrug

    Dapagliflozin 10 mg qd

  • PlaceboDrug

    Matched placebo qd

Study groups in NCT06619600
Study groupRoleWhat they receive
DapagliflozinExperimentalDapagliflozin 10 mg qd
Receives: Drug: Dapagliflozin
PlaceboPlacebo comparatorMatched placebo qd
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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]).

    Measured: 6 months

Secondary outcomes (4)

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

    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 (ΔPICP dapagliflozin group versus ΔPICP placebo group; [ΔPICP = PICP 6-month - PICP baseline]).

    Measured: 6 months

  2. N-terminal propeptide of type III (PIIINP)

    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 (ΔPIIINP dapagliflozin group versus ΔPIIINP placebo group; [ΔPIIINP = PIIINP 6-month - PIIINP baseline]).

    Measured: 6 months

  3. Galectin-3 procollagen (Gal-3)

    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 (ΔGal-3 dapagliflozin group versus ΔGal-3 placebo group; [ΔGal-3 = Gal-3 6-month - Gal-3 baseline]).

    Measured: 6 months

  4. High-Sensitivity cardiac Troponin I (hs-cTnI)

    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 (hs-cTnI dapagliflozin group versus hs-cTnI placebo group; [Δhs-cTnI = hs-cTnI 6-month - hs-cTnI baseline]).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start30 May 2021
  3. Primary completion31 Mar 2025 (estimated)
  4. Study completion31 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06619600
Sponsor's protocol ID
ESR-19-14489
Other IDs
2018-003105-25, 2018
Acronym
DAPA-STEMI
Status last verified
Sep 2024
First submitted
27 Sep 2024
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: To be discussed.

Publications

  • 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.

    PubMed 27544605

  • 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.

    PubMed 36303443

  • 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.

    PubMed 40558655

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin in people with ST-segment Elevation Myocardial Infarction (STEMI) and Diabetes Mellitus, run by Hospital Clinic of Barcelona at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extracellular volume (ECV, %) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06619600, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.

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