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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Experimental | Metformin will be started at 500 mg PO BID and pending lab values may be titrated to 1000 mg PO BID at 1 month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated Hemoglobin (HbA1c) | The HbA1c test measures how much glucose is bound to hemoglobin in the red blood cells. The test shows the average level of glucose in blood for the past 3 months (the average lifespan of red blood cells). If glucose levels have been high over recent weeks, the hemoglobin A1c test will be higher. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamara Horwich, MD, MS | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahmanson-UCLA Cardiomyopathy Center | Los Angeles | California | 90095 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metformin | Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metformin | Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Full Range | score on a scale | 3 months |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metformin | Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tamara Horwich, MD, MS | University of California Los Angeles | 310-825-8816 | thorwich@mednet.ucla.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006333 | Heart Failure |
| D018149 | Glucose Intolerance |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Left Ventricular Ejection Fraction (LVEF) |
Obtained from Echocardiography |
| 3 months |
| Creatinine Level as a Measure of Renal Function | Serum creatinine | 3 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Glycated Hemoglobin (HbA1c) | The HbA1c test measures how much glucose is bound to hemoglobin in the red blood cells. The test shows the average level of glucose in blood for the past 3 months (the average lifespan of red blood cells). If glucose levels have been high over recent weeks, the hemoglobin A1c test will be higher. | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin | 3 months |
|
|
|
| Secondary | Left Ventricular Ejection Fraction (LVEF) | Obtained from Echocardiography | Posted | Mean | Standard Deviation | percent ejection fraction | 3 months |
|
|
|
| Secondary | Creatinine Level as a Measure of Renal Function | Serum creatinine | Posted | Mean | Standard Deviation | mg/dL | 3 months |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
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| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006943 | Hyperglycemia |