Using Clonidine to Improve Leg Weakness in People With Heart Failure

April 26, 2018 updated by: Holly R Middlekauff, University of California, Los Angeles

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University Of California, Los Angeles Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Clonidine patch
Participants assigned to wear a clonidine patch.
Drug: Clonidine Patch
A clonidine patch (0.1 mg/week) to be worn for a period of 3 months.
Other Names:
  • Catapres-TTS
PLACEBO_COMPARATOR: Placebo
Participants assigned to wear a matching placebo patch.
Other: Matching Placebo Patch
A matching placebo patch to be worn for a period of 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Citrate Synthase Activity as an Estimate of Mitochondrial Activity
Time Frame: Baseline, 3 months
Baseline, 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Muscle Sympathetic Nerve Activity
Time Frame: Baseline, 3 months
Muscle sympathetic nerve activity was measured as bursts sympathetic nerve activity per minute.
Baseline, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Holly R. Middlekauff, MD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

March 6, 2009

First Submitted That Met QC Criteria

March 6, 2009

First Posted (ESTIMATE)

March 10, 2009

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2018

Last Update Submitted That Met QC Criteria

April 26, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 641 (OHSU eIRB)
  • R01HL084525 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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