Using Clonidine to Improve Leg Weakness in People With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Clonidine Patch; Matching Placebo Patch
Intervention type(s): Drug; Other
Intervention description(s): A clonidine patch (0.1 mg/week) to be worn for a period of 3 months.; A matching placebo patch to be worn for a period of 3 months.
Other intervention name(s): Catapres-TTS
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Leg Weakness; Skeletal Myopathy; Sympathetic Nerve Activity