Management of Diabetes With Metformin In Patients With Chronic Heart Failure

NCT01122316 | Completed Results

• 1 other identifier: 09-06-086-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Diabetes

Keywords

Heart Failure; Diabetes; Metformin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Glycated Hemoglobin (HbA1c)

  3 months

• Left Ventricular Ejection Fraction (LVEF)

  3 months

• Creatinine Level as a Measure of Renal Function

  3 months

Study Arms (1)

Metformin

EXPERIMENTAL

Drug: Metformin

Interventions

Metformin DRUG

3\. Metformin will be started at 500 mg PO BID and pending lab values may be titrated to 1000 mg PO BID at 1 month.

Metformin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current metformin therapy
• Previous intolerance to metformin therapy
• Renal dysfunction (creatinine clearance \< 60 ml/minute)
• History of lactic acidosis.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Ahmanson-UCLA Cardiomyopathy Center

Los Angeles, California, 90095-7368, United States

Location

MeSH Terms

Conditions

Heart Failure; Diabetes Mellitus

Interventions

Metformin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Tamara Horwich, MD, MS
• Organization: University of California Los Angeles

thorwich@mednet.ucla.edu

310-825-8816

Study Officials

• Tamara Horwich, MD, MS

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tamara Horwich, MD, MS

Study Record Dates

• First Submitted: May 12, 2010
• First Posted: May 13, 2010
• Study Start: September 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: September 4, 2020
• Results First Posted: September 4, 2020

Record last verified: 2020-08

Locations

US (1)