Status:
WITHDRAWN
Detection of Diffuse Scar in Patients With Diabetes
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Diabetes Mellitus, Type II
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
Brief Summary
People with diabetes are at an increased risk of heart attacks and heart failure, and it is important to be able to treat people with diabetes who are at risk for heart disease to prevent these outcom...
Detailed Description
This study will be conducted in TWO (2) PHASES: Phase 1: Prospective cohort study of patients with diabetes mellitus, in which index cardiac MRI will be done after screening to determine FIBROTIC IND...
Eligibility Criteria
Inclusion
- For PHASE I (Prospective Cohort Study to determine prognostic value of fibrotic index)
- Diabetes mellitus, type II
- Age \>= 40 years
- UKPDS 10 year Risk Score \> 15%
- Low risk stress test (defined explicitily in our protocol)
Exclusion
- 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:
- Concomitant cytochrome P450 (CYP3A4) inhibitors or inducers;
- Concomitant potassium supplementation or potassium sparing diuretics;
- Concomitant use of both ACE inhibitor and ARB therapy (at any dose);
- Renal dysfunction (GFR \< 50 ml/min or serum creatinine \> 1.5 mg/dL (as assessed at time of index CMR);
- Any urine microalbuminuria (as assessed at time of index CMR);
- Baseline (pre-therapy) serum potassium \> 5.0 mEq/L;
- Lack of reliable telephone contact number for relaying results or the need to discontinue drug therapy;
- Age \> 75 years (given the tendency toward renal insufficiency not captured by GFR, dehydration and/or concomitant illness)
- Women able to become pregnant (given the undefined risk of eplerenone therapy in pregnant women and newborns).
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01794091
Start Date
August 1 2013
End Date
August 1 2017
Last Update
November 6 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02114