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

This study is currently recruiting participants.
Verified April 2012 by University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
Tamara Horwich, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01573949
First received: March 29, 2012
Last updated: April 9, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetes
Heart Failure
 Drug: Metformin

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study: Metformin Therapy in Heart Failure Patients With Early Diabetes or at High Risk of Developing Diabetes (Pre-Diabetes)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • QOL [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline HgA1c at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change from baseline left ventricular ejection fraction (LVEF) at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change from baseline in creatinine (Cr) level at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    If a patient shows signs of renal dysfunction (Cr >1.5 in men or > 1.4 in women or creatinine clearance < 60 ml/minute) the patient will discontinue taking the metformin and discontinue participating in the study.


Estimated Enrollment: 15
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573949

Locations
United States, California
Ahmanson-UCLA Cardiomyopathy Center Recruiting
Los Angeles, California, United States, 90095
Contact: Tamara Horwich, MD     310-825-8816        
Contact: Tianne Larson, MSN     310-825-8676        
Principal Investigator: Tamara Horwich, MD            
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Tamara Horwich, MD, MS University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Tamara Horwich, Tamara Horwich, MD, MS, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01573949     History of Changes
Other Study ID Numbers: 11-002909
Study First Received: March 29, 2012
Last Updated: April 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Heart Failure
Diabetes
Pre-diabetes
 Early type II diabetes
Metformin
Pharmacotherapy with metformin for prevention of DM in HF patients with pre-diabetes (pre-DM) and glycemic control in HF patients with early type II DM

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Failure
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Heart Diseases
Cardiovascular Diseases
Hyperglycemia
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013