Phase 3
N=72
Impact of Diabetes on Left Ventricular Remodeling
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01052272 ↗Enrolled (actual)
72
Serious AEs
33.3%
Results posted
Dec 2012
Primary outcome: Primary: Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA) — 73.03; 78.06; 78.52; 79.03 ml/m^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ramipril (Drug); Candesartan cilexetil (Drug); Allopurinol (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA) |
73.03; 78.06; 78.52; 79.03; 74.10; 78.60 | — |
| PRIMARY Left Ventricular End-Diastolic Radius to Wall Thickness (LVED Radius/Wall Thickness) |
3.23; 3.14; 3.57; 3.45; 3.32; 3.39 | — |
| PRIMARY Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume (LVED Mass/LVEDV) |
0.92; 0.95; 0.86; 0.87; 0.87; 0.83 | — |
| PRIMARY Left Ventricular Ejection Fraction (LVEF) |
52.19; 56.36; 53.37; 52.68; 54.20; 56.82 | — |
| PRIMARY Left Ventricular End Systolic Volume Indexed to Body Surface Area (LVESV/BSA) |
36.20; 35.26; 37.91; 39.49; 34.77; 35.26 | — |
| PRIMARY LV End Systolic Maximum Shortening (LVES Max Shortening) |
15.81; 16.68; 15.84; 16.00; 16.88; 17.50 | — |
| PRIMARY Peak Early Filling Rate Normalized to EDV |
1.93; 2.01; 2.11; 2.0; 1.74; 2.02 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 21 years old or older
- 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:
- Confirmed (i.e., two or more readings) fasting blood glucose >126mg/dl; or
- Random glucose ≥200mg/dl; or
- 2 hour glucose ≥200mg/dl following 75g of glucose; or
- Current treatment with diet or oral agents directed at the control of hyperglycemia either alone or in combination with insulin; or
- Current treatment with insulin with no prior history of diabetic ketoacidosis.
Exclusion Criteria
- Type-1 diabetes.
- Class III or IV heart failure.
- Cardiomyopathy (including hypertrophic and amyloidosis).
- Congenital or pericardial diseases.
- Intolerance to either ACE inhibitor, AT1-RB or allopurinol.
- Renal failure with creatinine > 2.5 mg/dl.
- Renal artery stenosis.
- Severe comorbidity such as liver disease or malignancy.
- Pregnancy (negative pregnancy test and effective contraceptive methods are required prior to enrollment of females of childbearing potential (not post-menopausal or surgically sterilized).
- Chronic steroid use.
- Unable to understand or cooperate with protocol requirements.
- Severe claustrophobia.
- Presence of a pacemaker or non-removable hearing aid.
- Presence of metal clips in the body.
Data sourced from ClinicalTrials.gov (NCT01052272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.