Trial Outcomes & Findings for Using Clonidine to Improve Leg Weakness in People With Heart Failure (NCT NCT00858845)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

Baseline, 3 months

Results posted on

2018-05-24

Participant Flow

All heart failure patients were recruited from the Ahmanson-University of California, Los Angeles (UCLA) Cardiomyopathy Center between 2008-2011.

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.

Participant milestones

Participant milestones
Measure	Clonidine Patch Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months.	Placebo Participants were assigned to wear a matching placebo patch (weekly) for a treatment period of 3 months.
Overall Study STARTED	5	6
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Clonidine Patch Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months.	Placebo Participants were assigned to wear a matching placebo patch (weekly) for a treatment period of 3 months.
Overall Study Patient underwent heart transplant.	0	1

Baseline Characteristics

Using Clonidine to Improve Leg Weakness in People With Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clonidine Patch n=5 Participants Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months.	Placebo Patch n=6 Participants Participants were assigned to wear a matching placebo patch (0.1 mg/weekly) for a treatment period of 3 months.	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Female	NA participants n=5 Participants	NA participants n=7 Participants	4 participants n=5 Participants
Sex/Gender, Customized Male	NA participants n=5 Participants	NA participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: One patient randomized to placebo underwent urgent orthotopic heart transplantation before second measure could be obtained.

Outcome measures

Outcome measures
Measure	Clonidine Patch n=5 Participants Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months.	Placebo n=5 Participants Participants were assigned to wear a matching placebo patch (weekly) for a treatment period of 3 months
Change in Citrate Synthase Activity as an Estimate of Mitochondrial Activity	-0.3 micromole/min/wet weight Standard Error 0.09	0.07 micromole/min/wet weight Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: One patient randomized to placebo underwent urgent orthotopic heart transplantation before second measure could be obtained.

Fibers were typed as I or II according to presence of myosin heavy chain.

Outcome measures

Outcome measures
Measure	Clonidine Patch n=5 Participants Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months.	Placebo n=5 Participants Participants were assigned to wear a matching placebo patch (weekly) for a treatment period of 3 months
Change in Proportion of Type 1 Fibers	-4.6 percentage of fibers Standard Error 3.8	-5.6 percentage of fibers Standard Error 1.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3 months

Population: One patient randomized to placebo underwent urgent orthotopic heart transplantation before second measure could be obtained.

Muscle sympathetic nerve activity was measured as bursts sympathetic nerve activity per minute.

Outcome measures

Outcome measures
Measure	Clonidine Patch n=5 Participants Participants were assigned to wear a clonidine patch (0.1 mg/weekly) for a treatment period of 3 months.	Placebo n=5 Participants Participants were assigned to wear a matching placebo patch (weekly) for a treatment period of 3 months
Change in Muscle Sympathetic Nerve Activity	-4.3 bursts/min Standard Error 2.4	4.4 bursts/min Standard Error 8.8

Adverse Events

Clonidine Patch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Holly R. Middlekauff

University of California, Los Angeles (UCLA)

Phone: 310-206-6672

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place