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Completed

NCT Number: NCT00858845

Using Clonidine to Improve Leg Weakness in People With Heart Failure

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, Los Angeles Medical Center

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clonidine Patch

Drug

A clonidine patch (0.1 mg/week) to be worn for a period of 3 months.

Other names: Catapres-TTS

Matching Placebo Patch

Other

A matching placebo patch to be worn for a period of 3 months.

Primary outcomes

  1. Change in Citrate Synthase Activity as an Estimate of Mitochondrial Activity

    Time frame: Baseline, 3 months

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Clonidine and the Skeletal Myopathy of Heart Failure

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Mar 10, 2009
Registry last updated
May 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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