Impact of Diabetes on Left Ventricular Remodeling

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators hypothesize that in patients with diabetes and acute myocardial infarction (MI), Ang II type-1 receptor blockade (AT1RB) attenuates left ventricle (LV) remodeling to a greater extent than angiotensin converting enzyme (ACE) inhibitor therapy and that the addition of xanthine oxidase (XO) inhibitor, Allopurinol, results in further improvement in LV remodeling and function in the follow-up phase after MI.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborators: AstraZeneca; National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Allopurinol; Angiotensin-Converting Enzyme Inhibitors; Candesartan; Candesartan cilexetil; Ramipril

Criteria

Inclusion Criteria:

1. 21 years old or older

2. MI documented by increase in troponin > 0.78 ng/ml or CKMB ≥ 3% of total CK

Patients who have Type-2 diabetes defined by any one of the following:

3. Confirmed (i.e., two or more readings) fasting blood glucose >126mg/dl; or

4. Random glucose ≥200mg/dl; or

5. 2 hour glucose ≥200mg/dl following 75g of glucose; or

6. Current treatment with diet or oral agents directed at the control of hyperglycemia either alone or in combination with insulin; or

7. Current treatment with insulin with no prior history of diabetic ketoacidosis.

Exclusion Criteria:

1. Type-1 diabetes.

2. Class III or IV heart failure.

3. Cardiomyopathy (including hypertrophic and amyloidosis).

4. Congenital or pericardial diseases.

5. Intolerance to either ACE inhibitor, AT1-RB or allopurinol.

6. Renal failure with creatinine > 2.5 mg/dl.

7. Renal artery stenosis.

8. Severe comorbidity such as liver disease or malignancy.

9. Pregnancy (negative pregnancy test and effective contraceptive methods are required prior to enrollment of females of childbearing potential (not post-menopausal or surgically sterilized).

10. Chronic steroid use.

11. Unable to understand or cooperate with protocol requirements.

12. Severe claustrophobia.

13. Presence of a pacemaker or non-removable hearing aid.

14. Presence of metal clips in the body.