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

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

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 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	Diabetes Heart Failure
Intervention	Drug: Metformin
Phase	N/A
Sponsor	University of California, Los Angeles
Responsible Party	University of California, Los Angeles
ClinicalTrials.gov Identifier	NCT01573949
First Received	March 29, 2012
Last Updated	June 20, 2013
Last verified	June 2013

Tracking Information[ + expand ][ + ]

First Received Date	March 29, 2012
Last Updated Date	June 20, 2013
Start Date	December 2011
Estimated Primary Completion Date	December 2012
Current Primary Outcome Measures	QOL [Time Frame: 3 months] [Designated as safety issue: No]
Current 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.

Descriptive Information[ + expand ][ + ]

Brief Title	A Pilot Study: Metformin Therapy in Heart Failure Patients With Early Diabetes or at High Risk of Developing Diabetes (Pre-Diabetes)
Official Title	A Pilot Study: Metformin Therapy in Heart Failure Patients With Early Diabetes or at High Risk of Developing Diabetes (Pre-Diabetes)
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 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.
Detailed Description	Not Provided
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	Diabetes Heart Failure
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.
Study Arm (s)	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.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	8
Estimated Completion Date	December 2012
Estimated Primary Completion Date	December 2012
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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01573949
Other Study ID Numbers	11-002909
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	June 2013

Locations[ + expand ][ + ]