Using Clonidine to Improve Leg Weakness in People With Heart Failure
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|ClinicalTrials.gov Identifier: NCT00858845|
Recruitment Status : Completed
First Posted : March 10, 2009
Results First Posted : September 9, 2013
Last Update Posted : May 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: Clonidine Patch Other: Matching Placebo Patch||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Clonidine and the Skeletal Myopathy of Heart Failure|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||December 2012|
Experimental: Clonidine patch
Participants assigned to wear a clonidine patch.
Drug: Clonidine Patch
A clonidine patch (0.1 mg/week) to be worn for a period of 3 months.
Other Name: Catapres-TTS
Placebo Comparator: Placebo
Participants assigned to wear a matching placebo patch.
Other: Matching Placebo Patch
A matching placebo patch to be worn for a period of 3 months.
- Change in Citrate Synthase Activity as an Estimate of Mitochondrial Activity [ Time Frame: Baseline, 3 months ]
- Change in Proportion of Type 1 Fibers [ Time Frame: Baseline, 3 months ]Fibers were typed as I or II according to presence of myosin heavy chain.
- Change in Muscle Sympathetic Nerve Activity [ Time Frame: Baseline, 3 months ]Muscle sympathetic nerve activity was measured as bursts sympathetic nerve activity per minute.
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): NCT00858845
|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|