Heart MRI may reveal hidden danger in diabetics
NCT ID NCT01794091
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 However, the study was withdrawn before enrolling anyone, so no results are available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Expected to start
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Aug 2013
An estimate. Start dates often move.
- Expected to finish
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Aug 2017
An estimate. End dates often move.
- Lead sponsor
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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
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40 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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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.