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Trial record 66 of 112 for:    EPLERENONE

Detection of Diffuse Scar in Patients With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01794091
Recruitment Status : Unknown
Verified February 2013 by Raymond Y. Kwong, MD, Brigham and Women's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 18, 2013
Last Update Posted : February 18, 2013
Information provided by (Responsible Party):
Raymond Y. Kwong, MD, Brigham and Women's Hospital

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 outcomes. This study is looking at the importance of "diffuse scar tissue" that is found in the heart of diabetic people. We have discovered a way to detect diffuse scar tissue by cardiac MRI, a non-invasive test. In this study, we do cardiac MRI on diabetics with low risk stress test results and follow them for 5 years to see if the measure of scar tissue in the heart by MRI is related to events. If this study is positive, we will be able to use cardiac MRI scar tissue measurements to target those patients with diabetes who are at highest risk.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type II Drug: Eplerenone Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Comprehensive Stress-Perfusion Cardiac MRI Assessment of Diabetic Cardiomyopathy: Prognostic Role of the Fibrotic Index
Study Start Date : August 2013
Estimated Primary Completion Date : August 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Eplerenone

Arm Intervention/treatment
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.
Drug: Eplerenone
Eplerenone 25 mg daily for 6 months

Placebo Comparator: Sugar pill Drug: Placebo

Primary Outcome Measures :
  1. All cause mortality, cardiovascular death, myocardial infarction or stroke [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01794091

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Contact: Raymond Y Kwong, MD MPH 617-306-6495

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United States, Massachusetts
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Brigham and Women's Hospital

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Responsible Party: Raymond Y. Kwong, MD, Associate Professor - Medicine, Brigham and Women's Hospital Identifier: NCT01794091     History of Changes
Other Study ID Numbers: Fibrotic Index in Diabetics
First Posted: February 18, 2013    Key Record Dates
Last Update Posted: February 18, 2013
Last Verified: February 2013
Keywords provided by Raymond Y. Kwong, MD, Brigham and Women's Hospital:
Cardiac Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Antihypertensive Agents