Using Clonidine to Improve Leg Weakness in People With Heart Failure

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Holly R Middlekauff, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00858845
First received: March 6, 2009
Last updated: September 4, 2013
Last verified: September 2013
  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: 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

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Citrate Synthase Activity [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]
    Citrate synthesis is an estimate of mitochondrial activity


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • Muscle Sympathetic Nerve Activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Muscle 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: Clonidine patch
Participants will wear a clonidine patch.
Drug: Clonidine Patch
A clonidine patch (0.1 mg/week) will be worn for 3 months.
Other Name: Catapress-TTS

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
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858845

Locations
United States, California
University of California, Los Angeles Medical Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Holly R. Middlekauff, MD University of California, Los Angeles
  More Information

Publications:
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
Study First Received: March 6, 2009
Results First Received: June 19, 2013
Last Updated: September 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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014