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Detection of Diffuse Scar in Patients With Diabetes

Primary Purpose

Diabetes Mellitus, Type II

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Eplerenone

Placebo

About this trial

This is an interventional screening trial for Diabetes Mellitus, Type II focused on measuring Cardiac Magnetic Resonance Imaging, Diabetes

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Eplerenone

Sugar pill

Arm Description

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.

Outcomes

Primary Outcome Measures

All cause mortality, cardiovascular death, myocardial infarction or stroke

Secondary Outcome Measures

Full Information

NCT ID

NCT01794091

First Posted

February 15, 2013

Last Updated

February 15, 2013

Sponsor

Brigham and Women's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01794091

Brief Title

Detection of Diffuse Scar in Patients With Diabetes

Official Title

Comprehensive Stress-Perfusion Cardiac MRI Assessment of Diabetic Cardiomyopathy: Prognostic Role of the Fibrotic Index

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Unknown status

Study Start Date

August 2013 (undefined)

Primary Completion Date

August 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type II

Keywords

Cardiac Magnetic Resonance Imaging, Diabetes

7. Study Design

Primary Purpose

Screening

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Eplerenone

Arm Type

Experimental

Arm Description

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.

Arm Title

Sugar pill

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Eplerenone

Intervention Description

Eplerenone 25 mg daily for 6 months

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

All cause mortality, cardiovascular death, myocardial infarction or stroke

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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: 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Raymond Y Kwong, MD MPH

Phone

617-306-6495

rykwong@partners.org

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

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Detection of Diffuse Scar in Patients With Diabetes

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