N/A
Completed N=10
Management of Diabetes With Metformin In Patients With Chronic Heart Failure
Source: ClinicalTrials.gov NCT01122316 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Health-Related Quality of Life (HRQoL) — 56; 53 score on a scale
Summary
The Ahmanson-UCLA Cardiomyopathy Center is conducting a clinical research study that will assess the use of the medication metformin to improve quality of life, exercise capacity, and improved outcomes with patients that have both heart failure and diabetes.
If you participate in this study, you will receive the drug metformin for approximately 3 months. During the study you will undergo comprehensive testing which includes blood draws, an echocardiogram, and an magnetic resonance imaging (MRI)(if you do not have a pacemaker or defibrillator). You will also fill out a questionnaire and keep a blood glucose log.
You must be 18 years old to participate. The study drugs, study follow-up visits, and laboratory tests will be provided free of charge. Participants will be reimbursed up to $200 for their time and travel expenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Health-Related Quality of Life (HRQoL) |
56; 53 | — |
| SECONDARY Glycated Hemoglobin (HbA1c) |
9.1; 8.9 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF) |
22; 28 | — |
| SECONDARY Creatinine Level as a Measure of Renal Function |
1.04; 1.09 | — |
Eligibility Criteria
Inclusion Criteria
- Systolic HF of any etiology (left ventricular ejection fraction ≤ 40%)
- Previously-diagnosed, inadequately controlled DM (HbA1c≥7.5%)
- On any combination of anti-diabetic medications excluding metformin
Exclusion Criteria
- Current metformin therapy
- Previous intolerance to metformin therapy
- Renal dysfunction (creatinine clearance < 60 ml/minute)
- History of lactic acidosis.
Data sourced from ClinicalTrials.gov (NCT01122316). 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. Informational only — not medical advice.