Using Clonidine to Improve Leg Weakness in People With Heart Failure - Full Text View

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00858845

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 Drug: Placebo Patch	Phase IV

MedlinePlus related topics: Heart Failure Muscle Disorders

Drug Information available for: Clonidine Clonidine hydrochloride

U.S. FDA Resources

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

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Measures of skeletal myopathy [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sympathetic nerve activity [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]

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
1: Active Comparator Participants will wear a clonidine patch.	Drug: Clonidine Patch A clonidine patch (0.1 mg/week) will be worn for 3 months.
2: Placebo Comparator Participants will wear a placebo patch.	Drug: Placebo Patch A placebo patch 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

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

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

Contacts

Contact: Holly R. Middlekauff, MD

310-206-6672

hmiddlekauff@mednet.ucla.edu

Locations

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

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Holly R. Middlekauff, MD

University of California, Los Angeles

More Information

No publications provided

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

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Leg Weakness
Skeletal Myopathy
Sympathetic Nerve Activity

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 06, 2009