Heart TransplantPhase 1NCT01485757
Prospective L-arginine Study
A Phase 1 study testing L-arginine in people with Heart Transplant, run by University of Michigan at 1 site in United States.
Trial summary
HYPOTHESIS The investigators primary hypothesis is that peripheral endothelial function and exercise tolerance will be abnormal in the population of young heart transplant patients at baseline, and that each will show a trend towards improvement following a 12 week course of oral L-arginine, with regression towards… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Heart Transplant
- What is being tested?
- L-arginine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jul 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- University of Michigan Pediatric Heart Transplant Clinic patient.
- Greater than or equal to 8 years of age.
- Heart transplant between 1 and 8 years prior to enrollment in the study
Who cannot join
- Relative hypotension for age
- Refusal to participate
- Inability to cooperate with Endo-PAT testing
- Pregnant or nursing women.
- Insulin dependent diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Pediatric Heart Transplant Clinic
Ann Arbor, Michigan, 48109
About this study
Official title: Effect of Chronic Oral L-arginine Supplementation on Peripheral Endothelial Function and Exercise Tolerance in a Population of Young Heart Transplant Patients.
HYPOTHESIS The investigators primary hypothesis is that peripheral endothelial function and exercise tolerance will be abnormal in the population of young heart transplant patients at baseline, and that each will show a trend towards improvement following a 12 week course of oral L-arginine, with regression towards the baseline following the 12 week washout period.
- Conditions
- Heart Transplant
- Being tested
- L-arginine
- Keywords
- patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-arginineDrug
All study subjects will be treated with a 12 week (11-13 week) course of oral L-arginine at a dose of 6 g per day, divided into morning and evening doses of 3 g (3 1000 mg capsules or caplets).
| Study group | Role | What they receive |
|---|---|---|
| L-arginine | Experimental | Not described Receives: Drug: L-arginine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peripheral endothelial function from baseline following 12 week treatment course of L-arginine.
Endothelial function will be assessed at baseline as well as after a 12 week treatment course of L-arginine. A final measurement will be made following a 12 week washout period.
Measured: baseline and 12 weeks
Secondary outcomes (2)
Change from baseline in serum levels of oxidative stress markers
Serum markers of oxidative stress will be measured at baseline and after a 12 week treatment course of L-arginine. A final measurement will be made after a 12 week washout period.
Measured: baseline and 12 weeks
Change in exercise tolerance from baseline following a 12 week treatment course of L-arginine
Exercise tolerance will be assessed with a 6 minute walk at baseline and following a 12 week treatment course of L-arginine. A final measurement will be made after a 12 week washout period.
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Technical difficulty with Endo-PAT machine
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josh Friedland-Little, MD, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485757
- Sponsor's protocol ID
- HUM00035716
- Status last verified
- Jan 2017
- First submitted
- 29 Nov 2011
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chronic Oral L-arginine Supplementation on Peripheral Endothelial Function and Exercise Tolerance in a Population of Young Heart Transplant Patients.
- ClinicalTrials.gov ID
- NCT01485757
- Acronym / sponsor ID
- HUM00035716
- Conditions
- Heart Transplant
- Keywords
- patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Technical difficulty with Endo-PAT machine
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 5 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HYPOTHESIS The investigators primary hypothesis is that peripheral endothelial function and exercise tolerance will be abnormal in the population of young heart transplant patients at baseline, and that each will show a trend towards improvement following a 12 week course of oral L-arginine, with regression towards the baseline following the 12 week washout period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| L-arginine | Experimental | Drug: L-arginine |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- University of Michigan Pediatric Heart Transplant Clinic patient.
- Greater than or equal to 8 years of age.
- Heart transplant between 1 and 8 years prior to enrollment in the study
Key exclusion criteria (5 listed)
- Relative hypotension for age
- Refusal to participate
- Inability to cooperate with Endo-PAT testing
- Pregnant or nursing women.
- Insulin dependent diabetes
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 |
|---|---|---|
| L-arginineAll study subjects will be treated with a 12 week (11-13 week) course of oral L-arginine at a dose of 6 g per day, divided into morning and evening doses of 3 g (3 1000 mg capsules or caplets). | Drug | L-arginine |
Primary outcome
Change in peripheral endothelial function from baseline following 12 week treatment course of L-arginine.
Time frame: baseline and 12 weeks
Endothelial function will be assessed at baseline as well as after a 12 week treatment course of L-arginine. A final measurement will be made following a 12 week washout period.
2 secondary outcomes
Change from baseline in serum levels of oxidative stress markers
Time frame: baseline and 12 weeks
Change in exercise tolerance from baseline following a 12 week treatment course of L-arginine
Time frame: baseline and 12 weeks
Results and safety
The study was stopped early (reason given: Technical difficulty with Endo-PAT machine). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing L-arginine in people with Heart Transplant, run by University of Michigan 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 10 Jan 2017. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Technical difficulty with Endo-PAT machine). Results are not available in the source record.
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 peripheral endothelial function from baseline following 12 week treatment course of L-arginine. (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2017.