| ID | Type | Description | Link |
|---|---|---|---|
| R01HL084525 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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People with heart failure often have weakness in their leg muscles. This study will determine whether the leg weakness is due to very high adrenaline levels and whether the medication clonidine can improve leg weakness.
Heart failure is a common condition, affecting approximately 5 million people in the United States. People with heart failure are encouraged to exercise and lose weight. However, many people with heart failure develop weakness in their leg muscles, which can make exercise difficult. Increased sympathetic nerve activity, which involves the nerves that carry adrenaline, also occurs in people with heart failure. It is possible that the increased sympathetic nerve activity may actually cause the leg muscle weakness. Clonidine, a medication used to treat high blood pressure, has been found to decrease sympathetic nerve activity. This study will further examine the connection between leg weakness and sympathetic nerve activity. It will also evaluate the effectiveness of clonidine at decreasing leg weakness in people with heart failure. Results from this study may explain why some people with heart failure are unable to exercise and may help to identify ways in which leg strength can be increased.
This study will enroll people with heart failure. Participants will be randomly assigned to wear either a clonidine patch or a placebo patch for 3 months. Participants will wear the patch on their upper arm, and they will replace the patch each week. At study visits at baseline and Month 3, participants will undergo the following procedures:
There will be no follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clonidine patch | Experimental | Participants assigned to wear a clonidine patch. |
|
| Placebo | Placebo Comparator | Participants assigned to wear a matching placebo patch. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonidine Patch | Drug | A clonidine patch (0.1 mg/week) to be worn for a period of 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Citrate Synthase Activity as an Estimate of Mitochondrial Activity | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Proportion of Type 1 Fibers | Fibers were typed as I or II according to presence of myosin heavy chain. | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Muscle Sympathetic Nerve Activity | Muscle sympathetic nerve activity was measured as bursts sympathetic nerve activity per minute. | Baseline, 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holly R. Middlekauff, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles Medical Center | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23575739 | Result | Middlekauff HR, Verity MA, Horwich TB, Fonarow GC, Hamilton MA, Shieh P. Intact skeletal muscle mitochondrial enzyme activity but diminished exercise capacity in advanced heart failure patients on optimal medical and device therapy. Clin Res Cardiol. 2013 Aug;102(8):547-54. doi: 10.1007/s00392-013-0564-3. Epub 2013 Apr 11. |
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Of 44 heart failure patients interested, 25 were ineligible (medication changes (6), "too well" with either left ventricular ejection fraction(LVEF) >35% (3) or New York Heart Association (NYHA) Class I (2), transportation issues (4), morbidly obese (3), enrolled in exercise program (2), other (5)), and of the remaining 19 patients, 8 declined.
All heart failure patients were recruited from the Ahmanson-University of California, Los Angeles (UCLA) Cardiomyopathy Center between 2008-2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clonidine Patch | Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months. |
| FG001 | Placebo | Participants were assigned to wear a matching placebo patch (weekly) for a treatment period of 3 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clonidine Patch | Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months. |
| BG001 | Placebo Patch | Participants were assigned to wear a matching placebo patch (0.1 mg/weekly) for a treatment period of 3 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Citrate Synthase Activity as an Estimate of Mitochondrial Activity | One patient randomized to placebo underwent urgent orthotopic heart transplantation before second measure could be obtained. | Posted | Mean | Standard Error | micromole/min/wet weight | Baseline, 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 | Clonidine Patch | Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months. |
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This is a small trial, but it was not terminated early, and there were no technical issues.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Holly R. Middlekauff | University of California, Los Angeles (UCLA) | 310-206-6672 | hmiddlekauff@mednet.ucla.edu |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Matching Placebo Patch | Other | A matching placebo patch to be worn for a period of 3 months. |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change in Proportion of Type 1 Fibers | Fibers were typed as I or II according to presence of myosin heavy chain. | One patient randomized to placebo underwent urgent orthotopic heart transplantation before second measure could be obtained. | Posted | Mean | Standard Error | percentage of fibers | Baseline, 3 months |
|
|
|
| Other Pre-specified | Change in Muscle Sympathetic Nerve Activity | Muscle sympathetic nerve activity was measured as bursts sympathetic nerve activity per minute. | One patient randomized to placebo underwent urgent orthotopic heart transplantation before second measure could be obtained. | Posted | Mean | Standard Error | bursts/min | Baseline, 3 months |
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|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Placebo | Participants were assigned to wear a matching placebo patch (weekly) for a treatment period of 3 months. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D006571 |
| Heterocyclic Compounds |