A Pilot Study: Metformin Therapy in Heart Failure Patients With Early Diabetes or at High Risk of Developing Diabetes (Pre-Diabetes)
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|ClinicalTrials.gov Identifier: NCT01573949|
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : June 24, 2013
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 or disease||Intervention/treatment||Phase|
|Diabetes Heart Failure||Drug: Metformin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study: Metformin Therapy in Heart Failure Patients With Early Diabetes or at High Risk of Developing Diabetes (Pre-Diabetes)|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
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 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.
- QOL [ Time Frame: 3 months ]
- Change from baseline HgA1c at 3 months [ Time Frame: 3 months ]
- Change from baseline left ventricular ejection fraction (LVEF) at 3 months [ Time Frame: 3 months ]
- Change from baseline in creatinine (Cr) level at 3 months [ Time Frame: 3 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573949
|United States, California|
|Ahmanson-UCLA Cardiomyopathy Center|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Tamara Horwich, MD, MS||University of California, Los Angeles|