N/A
Completed N=7
A Pilot Study: Metformin Therapy in Heart Failure Patients With Early Diabetes or at High Risk of Developing Diabetes (Pre-Diabetes)
Source: ClinicalTrials.gov NCT01573949 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Health-Related Quality of Life (HRQoL) — 37; 37 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 in heart failure patients with pre-DM or early DM (type II).
If the patient participates in this study, the patient will receive the drug metformin for approximately 3 months. During the study the patient will undergo comprehensive testing which includes blood draws and echocardiograms. The patient will also fill out a questionnaire. The patient must be 18 years old to participate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Health-Related Quality of Life (HRQoL) |
37; 37 | — |
| SECONDARY Glycated Hemoglobin (HbA1c) |
6.1; 6.2 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF) |
25; 26 | — |
| SECONDARY Creatinine Level as a Measure of Renal Function |
1.1; 1.1 | — |
Eligibility Criteria
Inclusion Criteria
- symptomatic HF of any etiology
- age ≥ 18 years
- fasting blood sugar equal or greater than 100 mg/dL, or pre-DM (HbA1c 5.7 - 6.4%) or early DM (HbA1c ≥ 6.5%)
Exclusion Criteria
- current metformin therapy or other anti-diabetic therapy
- previous intolerance to metformin therapy
- renal dysfunction (Cr >1.5 in men or > 1.4 in women or creatinine clearance < 60 ml/minute)
- history of lactic acidosis
- current or planned pregnancy or breast-feeding
Data sourced from ClinicalTrials.gov (NCT01573949). 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.