Using Clonidine to Improve Leg Weakness in People With Heart Failure
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 5/26/2018 |
| Start Date: | May 2008 |
| End Date: | December 2012 |
Clonidine and the Skeletal Myopathy of 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.
whether the leg weakness is due to very high adrenaline levels and whether the medication
clonidine can improve leg weakness.
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.
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.
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
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