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Heart MRI may reveal hidden danger in diabetics

NCT ID NCT01794091

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to see if a special heart MRI could detect 'diffuse scar tissue' in people with type 2 diabetes and predict their risk of heart attacks or death. Researchers planned to follow participants for 5 years after a low-risk stress test. However, the study was withdrawn before enrolling anyone, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Expected to start

Aug 2013

An estimate. Start dates often move.

Expected to finish

Aug 2017

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

For PHASE I (Prospective Cohort Study to determine prognostic value of fibrotic index) Inclusion Criteria: * Diabetes mellitus, type II * Age \>= 40 years * UKPDS 10 year Risk Score \> 15% * Low risk stress test (defined explicitily in our protocol) Exclusion Criteria: * suspected or confirmed myocarditis or infiltrative disease (including hemochromatosis, sarcoid, or amyloid) * history of prior MI or coronary revascularization (by Q waves on electrocardiogram in 2 contiguous leads or by clinical history) * clinical HF (with prior hospital admission for HF or documentation of reduced LV ejection fraction after index CMR) * metallic hazards * hematocrit \< 30% (within 1 year of nuclear stress test) or history of active bleeding (within 3 months of stress test) * estimated GFR (by Modified Diet in Renal Disease) \< 45 ml/min/1.73m2 (within 2 weeks of planned CMR) * pregnancy * severe non-cardiac illness that or prognosis (e.g., end stage liver disease, malignancy, advanced HIV/AIDS) For PHASE 2: Inclusion Criteria: * Included in Phase I * Systolic blood pressure \> 140 mmHg on two occasions (at the initial nuclear stress test and at the index cardiac MRI) Exclusion criteria: 1. Concomitant cytochrome P450 (CYP3A4) inhibitors or inducers; 2. Concomitant potassium supplementation or potassium sparing diuretics; 3. Concomitant use of both ACE inhibitor and ARB therapy (at any dose); 4. Renal dysfunction (GFR \< 50 ml/min or serum creatinine \> 1.5 mg/dL (as assessed at time of index CMR); 5. Any urine microalbuminuria (as assessed at time of index CMR); 6. Baseline (pre-therapy) serum potassium \> 5.0 mEq/L; 7. Lack of reliable telephone contact number for relaying results or the need to discontinue drug therapy; 8. Age \> 75 years (given the tendency toward renal insufficiency not captured by GFR, dehydration and/or concomitant illness) 9. Women able to become pregnant (given the undefined risk of eplerenone therapy in pregnant women and newborns).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.