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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00858845 |
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.
Condition | Intervention | Phase |
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Heart Failure |
Drug: Clonidine Patch Drug: Placebo Patch |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Clonidine and the Skeletal Myopathy of Heart Failure |
Estimated Enrollment: | 50 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Participants will wear a clonidine patch.
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Drug: Clonidine Patch
A clonidine patch (0.1 mg/week) will be worn for 3 months.
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2: Placebo Comparator
Participants will wear a placebo patch.
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Drug: Placebo Patch
A placebo patch will be worn for 3 months.
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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.
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Holly R. Middlekauff, MD | 310-206-6672 | hmiddlekauff@mednet.ucla.edu |
United States, California | |
University of California, Los Angeles Medical Center | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Holly R. Middlekauff, MD 310-206-6672 hmiddlekauff@mednet.ucla.edu | |
Principal Investigator: Holly R. Middlekauff, MD |
Principal Investigator: | Holly R. Middlekauff, MD | University of California, Los Angeles |
Responsible Party: | University of California, Los Angeles ( Holly R. Middlekauff, MD ) |
Study ID Numbers: | 641, R01 HL084525 |
Study First Received: | March 6, 2009 |
Last Updated: | March 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00858845 History of Changes |
Health Authority: | United States: Federal Government |
Leg Weakness Skeletal Myopathy Sympathetic Nerve Activity |
Heart Failure Neurotransmitter Agents Heart Diseases Adrenergic alpha-Agonists Adrenergic Agents Asthenia Clonidine |
Cardiovascular Agents Antihypertensive Agents Adrenergic Agonists Muscular Diseases Analgesics Peripheral Nervous System Agents |
Sympatholytics Heart Failure Neurotransmitter Agents Heart Diseases Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Clonidine Physiological Effects of Drugs Cardiovascular Agents |
Antihypertensive Agents Adrenergic Agonists Pharmacologic Actions Autonomic Agents Sensory System Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents Analgesics Central Nervous System Agents |