- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01794091
Detection of Diffuse Scar in Patients With Diabetes
Comprehensive Stress-Perfusion Cardiac MRI Assessment of Diabetic Cardiomyopathy: Prognostic Role of the Fibrotic Index
Study Overview
Status
Conditions
Intervention / Treatment
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 INDEX. Patients are subsequently followed for 5 years for a primary endpoint (composite cardiovascular event).
Phase 2: Of the patients with "HIGH" FIBROTIC INDEX, 50 patients will be randomly selected and randomized 1:1 to placebo:eplerenone 25 mg daily for 6 months, and a repeat cardiac MRI will be done to assess the fibrotic index post-treatment.
Phase 2 is a PILOT study of 50 patients.
The inclusion/exclusion criteria for the different phases is shown below.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Raymond Y Kwong, MD MPH
- Phone Number: 617-306-6495
- Email: rykwong@partners.org
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Brigham and Women's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Sugar pill
|
|
Experimental: Eplerenone
In a subgroup of 50 patients, 25 will be randomized to eplerenone to assess effects on fibrotic index pre- and post-6 months of therapy.
|
Eplerenone 25 mg daily for 6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All cause mortality, cardiovascular death, myocardial infarction or stroke
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Physiological Effects of Drugs
- Antihypertensive Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Natriuretic Agents
- Diuretics
- Hormone Antagonists
- Mineralocorticoid Receptor Antagonists
- Diuretics, Potassium Sparing
- Eplerenone
Other Study ID Numbers
- Fibrotic Index in Diabetics
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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