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Trial record 39 of 326 for:    clonidine

Using Clonidine to Improve Leg Weakness in People With Heart Failure

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ClinicalTrials.gov Identifier: NCT00858845
Recruitment Status : Completed
First Posted : March 10, 2009
Results First Posted : September 9, 2013
Last Update Posted : May 24, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Holly R Middlekauff, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Heart Failure
Interventions Drug: Clonidine Patch
Other: Matching Placebo Patch
Enrollment 11
Recruitment Details All heart failure patients were recruited from the Ahmanson-University of California, Los Angeles (UCLA) Cardiomyopathy Center between 2008-2011.
Pre-assignment Details Of 44 heart failure patients interested, 25 were ineligible (medication changes (6), “too well” with either left ventricular ejection fraction(LVEF) >35% (3) or New York Heart Association (NYHA) Class I (2), transportation issues (4), morbidly obese (3), enrolled in exercise program (2), other (5)), and of the remaining 19 patients, 8 declined.
Arm/Group Title Clonidine Patch Placebo
Hide Arm/Group Description Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months. Participants were assigned to wear a matching placebo patch (weekly) for a treatment period of 3 months.
Period Title: Overall Study
Started 5 6
Completed 5 5
Not Completed 0 1
Reason Not Completed
Patient underwent heart transplant.             0             1
Arm/Group Title Clonidine Patch Placebo Patch Total
Hide Arm/Group Description Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months. Participants were assigned to wear a matching placebo patch (0.1 mg/weekly) for a treatment period of 3 months. Total of all reporting groups
Overall Number of Baseline Participants 5 6 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 11 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
6
 100.0%
11
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 11 participants
Female NA [1]  NA [2]  4
Male NA [2]  NA [2]  7
[1]
Data were not retained with detail needed to report by treatment arm.
[2]
Data were not retained with detail needed to report by treatment arm
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 6 participants 11 participants
5 6 11
1.Primary Outcome
Title Change in Citrate Synthase Activity as an Estimate of Mitochondrial Activity
Hide Description [Not Specified]
Time Frame Baseline, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
One patient randomized to placebo underwent urgent orthotopic heart transplantation before second measure could be obtained.
Arm/Group Title Clonidine Patch Placebo
Hide Arm/Group Description:
Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months.
Participants were assigned to wear a matching placebo patch (weekly) for a treatment period of 3 months
Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: micromole/min/wet weight
-0.3  (0.09) 0.07  (0.07)
2.Secondary Outcome
Title Change in Proportion of Type 1 Fibers
Hide Description Fibers were typed as I or II according to presence of myosin heavy chain.
Time Frame Baseline, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
One patient randomized to placebo underwent urgent orthotopic heart transplantation before second measure could be obtained.
Arm/Group Title Clonidine Patch Placebo
Hide Arm/Group Description:
Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months.
Participants were assigned to wear a matching placebo patch (weekly) for a treatment period of 3 months
Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: percentage of fibers
-4.6  (3.8) -5.6  (1.9)
3.Other Pre-specified Outcome
Title Change in Muscle Sympathetic Nerve Activity
Hide Description Muscle sympathetic nerve activity was measured as bursts sympathetic nerve activity per minute.
Time Frame Baseline, 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
One patient randomized to placebo underwent urgent orthotopic heart transplantation before second measure could be obtained.
Arm/Group Title Clonidine Patch Placebo
Hide Arm/Group Description:
Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months.
Participants were assigned to wear a matching placebo patch (weekly) for a treatment period of 3 months
Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: bursts/min
-4.3  (2.4) 4.4  (8.8)
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clonidine Patch Placebo
Hide Arm/Group Description Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months. Participants were assigned to wear a matching placebo patch (weekly) for a treatment period of 3 months.
All-Cause Mortality
Clonidine Patch Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/6 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Clonidine Patch Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clonidine Patch Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/6 (0.00%) 
This is a small trial, but it was not terminated early, and there were no technical issues.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Holly R. Middlekauff
Organization: University of California, Los Angeles (UCLA)
Phone: 310-206-6672
EMail: hmiddlekauff@mednet.ucla.edu
Layout table for additonal information
Responsible Party: Holly R Middlekauff, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00858845     History of Changes
Obsolete Identifiers: NCT01046344, NCT01826643
Other Study ID Numbers: 641
R01HL084525 ( U.S. NIH Grant/Contract )
First Submitted: March 6, 2009
First Posted: March 10, 2009
Results First Submitted: June 19, 2013
Results First Posted: September 9, 2013
Last Update Posted: May 24, 2018