A Pilot Study: Metformin Therapy in Heart Failure Patients With Early Diabetes or at High Risk of Developing Diabetes (Pre-Diabetes)

Heart Failure Clinical Trial

Official title:

A Pilot Study: Metformin Therapy in Heart Failure Patients With Early Diabetes or at High Risk of Developing Diabetes (Pre-Diabetes)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01573949
• Other study ID #: 11-002909
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: December 2012

Study information

• Verified date: August 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Glucose Intolerance
• Heart Failure
• Prediabetic State

Intervention

Drug:
• Metformin
Metformin will be started at 500 mg PO BID and pending lab values may be titrated to 1000 mg PO BID at 1 month for a duration of 3 months.

Locations

Country	Name	City	State
United States	Ahmanson-UCLA Cardiomyopathy Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-Related Quality of Life (HRQoL)	HRQoL as assessed by the Minnesota Living With Heart Failure Questionnaire (MLHFQ); The MLHFQ is a self-administered questionnaire for patients with HF, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on HRQoL, from 0 (none) to 5 (very much). It provides a total score range 0-105. Lower scores indicate better health-related quality of life (HRQoL).	3 months
Secondary	Glycated Hemoglobin (HbA1c)	The HbA1c test measures how much glucose is bound to hemoglobin in the red blood cells. The test shows the average level of glucose in blood for the past 3 months (the average lifespan of red blood cells). If glucose levels have been high over recent weeks, the hemoglobin A1c test will be higher.	3 months
Secondary	Left Ventricular Ejection Fraction (LVEF)	Obtained from Echocardiography	3 months
Secondary	Creatinine Level as a Measure of Renal Function	Serum creatinine	3 months