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

Tracking Information

First Received Date ^ICMJE

March 6, 2009

Last Updated Date

July 10, 2009

Start Date ^ICMJE

May 2008

Estimated Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00858845 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Using Clonidine to Improve Leg Weakness in People With Heart Failure

Official Title ^ICMJE

Clonidine and the Skeletal Myopathy of Heart Failure

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Heart Failure

Intervention ^ICMJE

Drug: Clonidine Patch
A clonidine patch (0.1 mg/week) will be worn for 3 months.
Drug: Placebo Patch
A placebo patch will be worn for 3 months.

Study Arms / Comparison Groups

1: Active Comparator
Participants will wear a clonidine patch.

Intervention: Drug: Clonidine Patch
2: Placebo Comparator
Participants will wear a placebo patch.

Intervention: Drug: Placebo Patch

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2011

Estimated Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Holly R. Middlekauff, MD

310-206-6672

hmiddlekauff@mednet.ucla.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00858845

Responsible Party

Holly R. Middlekauff, MD, University of California, Los Angeles

Study ID Numbers ^ICMJE

641, R01 HL084525

Study Sponsor ^ICMJE

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Holly R. Middlekauff, MD

University of California, Los Angeles

Information Provided By

National Heart, Lung, and Blood Institute (NHLBI)

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP