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Using Clonidine to Improve Leg Weakness in People With Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00858845
Recruitment Status : Completed
First Posted : March 10, 2009
Results First Posted : September 9, 2013
Last Update Posted : May 24, 2018
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Holly R Middlekauff, University of California, Los Angeles

Brief Summary:
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 or disease Intervention/treatment Phase
Heart Failure Drug: Clonidine Patch Other: Matching Placebo Patch Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Change in Citrate Synthase Activity as an Estimate of Mitochondrial Activity [ Time Frame: Baseline, 3 months ]

Secondary Outcome Measures :
  1. 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.

Other Outcome Measures:
  1. Change in Muscle Sympathetic Nerve Activity [ Time Frame: Baseline, 3 months ]
    Muscle sympathetic nerve activity was measured as bursts sympathetic nerve activity per minute.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00858845

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United States, California
University of California, Los Angeles Medical Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Holly R. Middlekauff, MD University of California, Los Angeles
Publications of Results:
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Responsible Party: Holly R Middlekauff, Professor, University of California, Los Angeles Identifier: NCT00858845    
Obsolete Identifiers: NCT01046344, NCT01826643
Other Study ID Numbers: 641
R01HL084525 ( U.S. NIH Grant/Contract )
First Posted: March 10, 2009    Key Record Dates
Results First Posted: September 9, 2013
Last Update Posted: May 24, 2018
Last Verified: April 2018
Keywords provided by Holly R Middlekauff, University of California, Los Angeles:
Leg Weakness
Skeletal Myopathy
Sympathetic Nerve Activity
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action