Management of Diabetes With Metformin In Patients With Chronic Heart Failure | RxWiki

Management of Diabetes With Metformin In Patients With Chronic Heart Failure

Overview[ - collapse ][ - ]

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 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.
Condition	Heart Failure Diabetes
Intervention	Drug: Metformin
Phase	N/A
Sponsor	University of California, Los Angeles
Responsible Party	University of California, Los Angeles
ClinicalTrials.gov Identifier	NCT01122316
First Received	May 12, 2010
Last Updated	March 29, 2012
Last verified	March 2012

Tracking Information[ + expand ][ + ]

First Received Date	May 12, 2010
Last Updated Date	March 29, 2012
Start Date	September 2009
Estimated Primary Completion Date	January 2012
Current Primary Outcome Measures	QOL [Time Frame: 3 months] [Designated as safety issue: No]
Current Secondary Outcome Measures	HbA1c [Time Frame: 3 months] [Designated as safety issue: No] LVEF [Time Frame: 3 months] [Designated as safety issue: No] renal function [Time Frame: 3 months] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Management of Diabetes With Metformin In Patients With Chronic Heart Failure
Official Title	Management of Diabetes With Metformin In Patients With Chronic Heart Failure
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.
Detailed Description	Heart failure (HF) affects 5 million individuals in the United States including over 10% of elderly persons >75 years. HF mortality is high, with approximately 20% 1-year risk of death (1). Diabetes (DM) is a common co-morbidity in patients with HF, present in approximately 25% of stable outpatients and 40% of hospitalized patients with HF (2). Diabetes in HF patients is associated with higher mortality (3,4). Hyperglycemia is independently associated with hospitalization for HF, longer length of stay during HF hospitalization, as well as higher in-hospital HF mortality (5-7). Furthermore, HF patients with more symptoms and worse functional status are more likely to have insulin resistance (8,9). Despite the abundance of evidence linking diabetes, insulin resistance, and hyperglycemia to impaired functional status and worse outcomes in patients with HF, there is lack of data and guidelines on optimal strategies to manage diabetes in patients with chronic HF. In retrospective studies, many diabetes medications in HF have been associated with harm including insulin, thiazolidinediones, and sulfonylureas (10). The only anti-hyperglycemic medication that has been associated in retrospective studies with benefit in patients with HF and diabetes is metformin, which recently had its "black box warning" in HF lifted by the FDA, although most physicians are unaware of the change in labeling (10-12). Our analysis of data on 401 advanced, systolic HF patients with DM followed at the Ahmanson-UCLA Cardiomyopathy Center also found metformin therapy to be associated with improvement of left ventricular ejection fraction (LVEF) as well as decreased 1-year mortality (figure 1)(13). Glycemic control in HF patients has not been prospectively studied; however, improved glycemic control has potential benefits in HF, including improvement of myocardial glucose utilization, decrease of potentially cardiotoxic free fatty acids, and reduced accumulation of myocardial collagen and advanced glycation end-products (14,15). Metformin therapy, compared to insulin and other antidiabetic medications, has potentially beneficial mechanisms of action in HF including insulin sensitization, improvement in lipid profiles, and more efficient myocardial metabolism (16,17). The purpose of this study is to gather pilot data for an anticipated comprehensive study DM management in HF, with the goal of NIH funding.
Study Type	Interventional
Study Phase	N/A
Study Design	Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Heart Failure Diabetes
Intervention	Drug: Metformin 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.
Study Arm (s)	Experimental: Metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	9
Estimated Completion Date	January 2012
Estimated Primary Completion Date	January 2012
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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01122316
Other Study ID Numbers	09-06-086-02
Has Data Monitoring Committee	No
Information Provided By	University of California, Los Angeles
Study Sponsor	University of California, Los Angeles
Collaborators	Not Provided
Investigators	Principal Investigator: Tamara Horwich, MD, MS University of California, Los Angeles
Verification Date	March 2012

Locations[ + expand ][ + ]