Detection of Diffuse Scar in Patients With Diabetes

NCT01794091 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: Fibrotic Index in Diabetics
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type II

Keywords

Cardiac Magnetic Resonance Imaging; Diabetes

Outcome Measures

Primary Outcomes (1)

• All cause mortality, cardiovascular death, myocardial infarction or stroke

  5 years

Study Arms (2)

Eplerenone

EXPERIMENTAL

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

Sugar pill

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Eplerenone DRUG

Eplerenone 25 mg daily for 6 months

Eplerenone

Placebo DRUG

Sugar pill

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes mellitus, type II
• Age \>= 40 years
• UKPDS 10 year Risk Score \> 15%
• Low risk stress test (defined explicitily in our protocol)

You may not qualify if:

• 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:
• Included in Phase I
• Systolic blood pressure \> 140 mmHg on two occasions (at the initial nuclear stress test and at the index cardiac MRI)
• 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);

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Medicine

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: February 18, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 6, 2025

Record last verified: 2025-11

Locations

US (1)