Using Clonidine to Improve Leg Weakness in People With Heart Failure
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Purpose
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 |
|---|---|---|
|
Heart Failure |
Drug: Clonidine Patch |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Clonidine and the Skeletal Myopathy of Heart Failure |
- citrate synthase activity [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]Citrate synthesis is an estimate of mitochondrial activity
- Muscle fiber type [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]Fibers witll be typed as I or II according to presence of myosin heavy chain
- Muslce sympathetic nerve activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]Muslce sympathetic nerve activity will be measured as bursts sympathetic nerve activity per minute.
| Enrollment: | 11 |
| Study Start Date: | May 2008 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Participants will wear a clonidine patch.
|
Drug: Clonidine Patch
A clonidine patch (0.1 mg/week) will be worn for 3 months.
|
Detailed Description:
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:
- Sympathetic nerve activity recording, which will record nerve activity in the lower leg, using small electrodes inserted through the skin
- Muscle biopsy, in which a small piece of muscle tissue will be obtained from participants' legs
- Heart rate and blood pressure measurements
- Arterial baroreceptor measurements, in which the nerves in the body that respond to changes in blood pressure will be examined while participants receive different medications to increase and decrease their blood pressure
- Echocardiography to obtain images of the heart
- Magnetic resonance scan of the leg
- Passive exercise procedure, in which study researchers will conduct an arm exercise with participants
There will be no follow-up visits.
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Heart failure
Exclusion Criteria:
- Currently on Coumadin therapy
- Experienced a heart attack in the 3 months before study entry
- Medically unable to receive clonidine
- Advanced kidney or liver disease
Contacts and Locations| United States, California | |
| University of California, Los Angeles Medical Center | |
| Los Angeles, California, United States, 90095 | |
| Principal Investigator: | Holly R. Middlekauff, MD | University of California, Los Angeles |
More Information
No publications provided
| Responsible Party: | Holly R Middlekauff, Professor, University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00858845 History of Changes |
| Obsolete Identifiers: | NCT01046344, NCT01826643 |
| Other Study ID Numbers: | 641, R01HL084525, R01 HL084525 |
| Study First Received: | March 6, 2009 |
| Last Updated: | April 4, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of California, Los Angeles:
|
Leg Weakness Skeletal Myopathy Sympathetic Nerve Activity |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Clonidine Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympatholytics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013