Detection of Diffuse Scar in Patients With Diabetes

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Raymond Y. Kwong, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01794091
First received: February 15, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type II
Drug: Eplerenone
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Comprehensive Stress-Perfusion Cardiac MRI Assessment of Diabetic Cardiomyopathy: Prognostic Role of the Fibrotic Index

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • All cause mortality, cardiovascular death, myocardial infarction or stroke [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2013
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01794091

Contacts
Contact: Raymond Y Kwong, MD MPH 617-306-6495 rykwong@partners.org

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

No publications provided

Responsible Party: Raymond Y. Kwong, MD, Associate Professor - Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01794091     History of Changes
Other Study ID Numbers: Fibrotic Index in Diabetics
Study First Received: February 15, 2013
Last Updated: February 15, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
Cardiac Magnetic Resonance Imaging
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Cardiomyopathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Diabetes Complications
Eplerenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014