Heart FailurePhase 4NCT00858845
Using Clonidine to Improve Leg Weakness in People With Heart Failure
A Phase 4 study testing Clonidine Patch in people with Heart Failure, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Clonidine Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Dec 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart failure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles Medical Center
Los Angeles, California, 90095
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Clonidine Patch, Matching Placebo Patch
- Keywords
- Leg Weakness, Skeletal Myopathy, Sympathetic Nerve Activity
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clonidine PatchDrug
Also called Catapres-TTS
A clonidine patch (0.1 mg/week) to be worn for a period of 3 months.
Matching Placebo PatchOther
A matching placebo patch to be worn for a period of 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Clonidine patch | Experimental | Participants assigned to wear a clonidine patch. Receives: Drug: Clonidine Patch |
| Placebo | Placebo comparator | Participants assigned to wear a matching placebo patch. Receives: Other: Matching Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Citrate Synthase Activity as an Estimate of Mitochondrial Activity
Measured: Baseline, 3 months
Secondary outcomes (1)
Change in Proportion of Type 1 Fibers
Fibers were typed as I or II according to presence of myosin heavy chain.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startMay 2008
- Primary completionMar 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Holly R Middlekauff, University of California, Los Angeles
- Investigators
- Holly R. Middlekauff, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858845
- Sponsor's protocol ID
- 641
- Other IDs
- R01HL084525
- Status last verified
- Apr 2018
- First submitted
- 6 Mar 2009
- Last updated
- 24 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23575739
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clonidine and the Skeletal Myopathy of Heart Failure
- ClinicalTrials.gov ID
- NCT00858845
- Acronym / sponsor ID
- 641
- Conditions
- Heart Failure
- Keywords
- Leg Weakness, Skeletal Myopathy, Sympathetic Nerve Activity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Mar 2009 (estimated)
- Results
- Posted 9 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clonidine patch | Experimental | Drug: Clonidine PatchParticipants assigned to wear a clonidine patch. |
| Placebo | Placebo comparator | Other: Matching Placebo PatchParticipants assigned to wear a matching placebo patch. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Heart failure
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clonidine PatchAlso: Catapres-TTSA clonidine patch (0.1 mg/week) to be worn for a period of 3 months. | Drug | Clonidine patch |
| Matching Placebo PatchA matching placebo patch to be worn for a period of 3 months. | Other | Placebo |
Primary outcome
Change in Citrate Synthase Activity as an Estimate of Mitochondrial Activity
Time frame: Baseline, 3 months
1 secondary outcome
Change in Proportion of Type 1 Fibers
Time frame: Baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23575739Middlekauff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly R. Middlekauff, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clonidine Patch in people with Heart Failure, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Citrate Synthase Activity as an Estimate of Mitochondrial Activity (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00858845, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2018.