Using Clonidine to Improve Leg Weakness in People With Heart Failure
Clonidine and the Skeletal Myopathy of Heart Failure
2 other identifiers
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 heart-failure
Started May 2008
Longer than P75 for phase_4 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 6, 2009
CompletedFirst Posted
Study publicly available on registry
March 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
September 9, 2013
CompletedMay 24, 2018
April 1, 2018
2.8 years
March 6, 2009
June 19, 2013
April 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Citrate Synthase Activity as an Estimate of Mitochondrial Activity
Baseline, 3 months
Secondary Outcomes (1)
Change in Proportion of Type 1 Fibers
Baseline, 3 months
Other Outcomes (1)
Change in Muscle Sympathetic Nerve Activity
Baseline, 3 months
Study Arms (2)
Clonidine patch
EXPERIMENTALParticipants assigned to wear a clonidine patch.
Placebo
PLACEBO COMPARATORParticipants assigned to wear a matching placebo patch.
Interventions
A clonidine patch (0.1 mg/week) to be worn for a period of 3 months.
Eligibility Criteria
You may qualify if:
- Heart failure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, Los Angeles Medical Center
Los Angeles, California, 90095, United States
Related Publications (1)
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.
PMID: 23575739RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This is a small trial, but it was not terminated early, and there were no technical issues.
Results Point of Contact
- Title
- Dr. Holly R. Middlekauff
- Organization
- University of California, Los Angeles (UCLA)
Study Officials
- PRINCIPAL INVESTIGATOR
Holly R. Middlekauff, MD
University of California, Los Angeles
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 6, 2009
First Posted
March 10, 2009
Study Start
May 1, 2008
Primary Completion
March 1, 2011
Study Completion
December 1, 2012
Last Updated
May 24, 2018
Results First Posted
September 9, 2013
Record last verified: 2018-04