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CompletedNCT06903754ISGTL2-MORMIUpdated Sep 15, 2025

ISGLT2 in Patients Without DM With Acute MI

An observational study in Acute Coronary Syndromes and Heart Failure, sponsored by Mohammed VI University Hospital. Completed at 1 site in Morocco. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Mohammed VI University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
450
Sex
All
01

Study summary

This study will evaluate the effect of ISGLT2 (Dapagliflozin or Empalgliflozin), administered once daily in addition to standard of care treatments for non-diabetic patients with myocardial infarction (MI) treated with PCI, on hospitalization for heart failure, readmissions for acute coronary syndrome and all-cause mortality.

Read the detailed description

This is a single-center, prospective study in non-diabetic patients with acute coronary syndrome (ACS) (ST elevation (STEMI) or non-ST elevation (NSTEMI) with left ventricular systolic dysfunction (Defined as Ejection Fraction\<50% assessed by 2D Simson Bi-plane echocardiography) or evidence of acute de Novo heart failure. The study will assess the effect of dapagliflozin or empagliflozin versus placebo, administered once daily in addition to standard therapy, on HF hospitalizations, all-cause deaths and ACS readmissions.

02

Conditions studied

  • Acute Coronary Syndromes
  • Heart Failure

Keywords

  • Acute coronary syndronme
  • ISGLT2
  • Heart failure
03

In context

Acute Coronary Syndrome

1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.

This study's enrollment of 450 is close to the median of 500 across 590 observational studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Mohammed VI University Hospital is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patient with Acute coronary syndrome

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant must approved the .
  • Confirmed MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al 2019).
  • Evidence of impaired regional or global LV systolic function at any timepoint during current MI-related hospitalisation with \<50%(established with echocardiogram, radionuclide ventriculogram, contrast angiography or cardiac MRI) or Symptoms of Acute heart failure without cardiogenic Shock.
  • Hemodynamically stable (no episodes of symptomatic hypotension, or arrhythmia with haemodynamic compromise in the last 24 hours).

Exclusion criteria

Exclusion Criteria:

  • Known type 1 diabetes mellitus (T1DM) or T2DM at the time for admission.
  • Chronic symptomatic HF with a prior HHF within the last year and known reduced (LVEF≤40 %), documented before the current MI hospitalization.
  • Patients with cardiogenic shock who received vasoactive drugs during index.
  • Hospitalization Severe ( \<20 mL/min/1.73 m2 by local laboratory), unstable or rapidly progressing renal disease at the time of randomization
  • Severe hepatic impairment ( class C) at the time of inclusion into the trial.
  • Active requiring treatment at the time of screening.
  • Any non-CV condition, eg malignancy, with a of less than one years based on the investigator´s clinical judgement.
  • Currently on treatment, or with an indication for treatment, with a sodium glucose co-transporter 2 inhibitor (SGLT2-inhibitor)
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
450 participants (actual)
Patient registry
No

Groups and cohorts

  • Without ISGLT2

    Patients for whom we will not prescribe ISGLT2

    Drug: With ISGLT2

Interventions

  • DrugWith ISGLT2

    Patients for whom we will prescribe ISGLT2

06

What researchers measure

Primary outcomes

  1. Primary endpoints

    Time to the first occurrence of any of the components of this composite: hospitalization for heart failure (HHF), Non fatal Myocardial infarction (MI) or Death from all causes

    Time frame: 50 months

Secondary outcomes

  1. Secondary outcomes

    Time to the first occurrence of a fatal or a non-fatal MI \[Time Frame: From admission visit (Day 0) up to approximately 4.2years\] Time to first hospitalisation for Heat failure \[Time Frame: From admission visit (Day 0) up to approximately 3 years\] Time to death of any cause \[Time Frame: From admission visit (Day 0) up to approximately 4.2 years\] Time to new onset of type 2 diabetes mellitus (T2DM) post discharge \[Time Frame: From admission (Day 0) up to approximately 4.2 years\] Time to new onset atrial fibrilation (AF) post discharge \[Time Frame: From admission visit (Day 0) up to approximately 4.2 years\]

    Time frame: 50 months

07

Study locations

1 site
  • Mohammed VI university hospital oujda
    OUDA, Morocco
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2021 to primary completion in Dec 2024, 38 months.

Of 243 non-industry observational studies under Acute Coronary Syndrome, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's 38 months is close to that.

Counting every sponsor, half of 277 studies reached it within 35 months; a quarter within 18 and three quarters within 68.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 22, 2025
First posted
Apr 1, 2025
StartActual
Oct 1, 2021
Primary completionActual
Dec 31, 2024
CompletionActual
Dec 31, 2024
Last update
Sep 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06903754
Lead sponsor
Mohammed VI University Hospital
Responsible party
BOUCHLARHEM AMINE (CLINICAL CARDIOLOGIST, Mohammed VI University Hospital) — Principal investigator
First posted
Apr 1, 2025
Start date
Oct 1, 2021
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Sep 15, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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