Using Clonidine to Improve Leg Weakness in People With Heart Failure

NCT ID: NCT00858845

Last Updated: 2018-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2012-12-31

Brief 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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Clonidine patch

Participants assigned to wear a clonidine patch.

Group Type: EXPERIMENTAL

Clonidine Patch

Intervention Type: DRUG

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

Placebo

Participants assigned to wear a matching placebo patch.

Group Type: PLACEBO_COMPARATOR

Matching Placebo Patch

Intervention Type: OTHER

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

Interventions

Clonidine Patch

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

Intervention Type: DRUG

Matching Placebo Patch

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

Intervention Type: OTHER

Other Intervention Names

Catapres-TTS

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Holly R Middlekauff

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Holly R. Middlekauff, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California, Los Angeles Medical Center

Los Angeles, California, United States

Countries

United States

References

Middlekauff HR, Verity MA, Horwich TB, Fonarow GC, Hamilton MA, Shieh P. Intact skeletal muscle mitochondrial enzyme activity but diminished exercise capacity in advanced heart failure patients on optimal medical and device therapy. Clin Res Cardiol. 2013 Aug;102(8):547-54. doi: 10.1007/s00392-013-0564-3. Epub 2013 Apr 11.

Reference Type: RESULT

PMID: 23575739 (View on PubMed)

Other Identifiers

R01HL084525

Identifier Type: NIH

Identifier Source: secondary_id

View Link

641

Identifier Type: -

Identifier Source: org_study_id

NCT01046344

Identifier Type: -

Identifier Source: nct_alias

NCT01826643

Identifier Type: -

Identifier Source: nct_alias