Heart TransplantationP1A3CNCT00780637
Brachial Artery t-PA Release in Heart Transplant Recipients
A study testing Bradykinin in people with Heart Transplantation, run by Vanderbilt University at 1 site in United States.
Trial summary
Bradykinin stimulates t-PA release from intact vessels, but not from endothelial cells in culture. It has been proposed that the nerves of blood vessels are the source of bradykinin stimulated t-PA release. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplantation
- What is being tested?
- Bradykinin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to May 2011
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years and greater who have undergone heart transplantation
- Healthy
Who cannot join
- PVC < 30
- Hypertensive subjects on ACE inhibitors
- Pregnant or nursing mothers
- Diabetic with HbA1C > 7.5 or stigmata of end organ damage (neuropathy, retinopathy, nephropathy, cardiomyopathy)
- Cholesterol > 30 mg/dL above NCEP accepted level based on cardiac risk.
- Triglycerides > 200
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- Previously diagnosed obstructive coronary artery disease
- Renal insufficiency (Creatinine ≥ 1.5 mg/dl)
- History of cerebrovascular disease
- Any chronic inflammatory disease (rheumatologic, inflammatory bowel disease, etc)
- Uncontrolled Stage 2 Hypertension (160/100 mmHg), or end organ damage due to hypertension (left ventricular hypertrophy, atrial fibrillation, hematuria, renal insufficiency, prior cerebrovascular disease).
- Angiotensin converting enzyme inhibitor use
- Coagulopathy (INR ≥ 1.5, PTT ≥ 150% of control)
- Peripheral Vascular Disease
- Other chronic medical illnesses at the discretion of the investigators
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Characterization of Brachial Arterial t-PA Release, Vasodilator Function, and Vascular Compliance and Correlation With Fibrinolytic Balance, Oxidative Stress, and Inflammation Measures in Heart Transplant Recipients (SCCOR Project 1, Aim 3C)
Bradykinin stimulates t-PA release from intact vessels, but not from endothelial cells in culture. It has been proposed that the nerves of blood vessels are the source of bradykinin stimulated t-PA release. In order tho test this hypothesis, we intend to infuse bradykinin into the brachial (arm) artery and the coronary arteries of heart transplant recipients and control subjects. This is because heart transplant recipients do not have nerves to their coronary arteries.
This protocol studies the effects of bradykinin on t-PA release in the forearm of transplant recipients. The brachial artery has intact nerves.
Separate protocols address coronary artery infusions in healthy subjects and transplant recipients and forearm infusions in healthy subjects.
- Conditions
- Heart Transplantation
- Being tested
- Bradykinin
- Keywords
- Heart Transplant, Endothelial Function, Fibrinolysis, Transplant recipients at baseline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BradykininDrug
Patients receive 0, 10, 20, and 40 ng/100cc forearm volume/min of bradykinin intrabrachial.
| Study group | Role | What they receive |
|---|---|---|
| Bradykinin | Experimental | Patients receive 0, 10, 20, and 40 ng/min/100cc forearm volume of intrabrachial bradykinin, for 5 minutes at each dose. Forearm blood flow will be measured by strain gauge plethysmography, blood samples will be obtained to measure t-PA, PAI-1 at each dose. FMD and Radial artery tonometry will also be performed under resting conditions. Receives: Drug: Bradykinin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak t-PA release
Measured: Single Study Visit
Secondary outcomes (1)
t-PA release at various doses
Measured: Single Study Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionJan 2011
- Study completionMay 2011
Why it stopped: Bradykinin Shortage, SCCOR expired prior to BK availability, lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Muldowney, Vanderbilt University
- Investigators
- James AS Muldowney, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780637
- Sponsor's protocol ID
- 070517
- Acronym
- P1A3C
- Status last verified
- Jul 2016
- First submitted
- 24 Oct 2008
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Brachial Arterial t-PA Release, Vasodilator Function, and Vascular Compliance and Correlation With Fibrinolytic Balance, Oxidative Stress, and Inflammation Measures in Heart Transplant Recipients (SCCOR Project 1, Aim 3C)
- ClinicalTrials.gov ID
- NCT00780637
- Acronym / sponsor ID
- P1A3C / 070517
- Conditions
- Heart Transplantation
- Keywords
- Heart Transplant, Endothelial Function, Fibrinolysis, Transplant recipients at baseline
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Bradykinin Shortage, SCCOR expired prior to BK availability, lack of enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 27 Oct 2008 (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.
Bradykinin stimulates t-PA release from intact vessels, but not from endothelial cells in culture. It has been proposed that the nerves of blood vessels are the source of bradykinin stimulated t-PA release. In order tho test this hypothesis, we intend to infuse bradykinin into the brachial (arm) artery and the coronary arteries of heart transplant recipients and control subjects. This is because heart transplant recipients do not have nerves to their coronary arteries.
This protocol studies the effects of bradykinin on t-PA release in the forearm of transplant recipients. The brachial artery has intact nerves.
Separate protocols address coronary artery infusions in healthy subjects and transplant recipients and forearm infusions in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bradykinin | Experimental | Drug: BradykininPatients receive 0, 10, 20, and 40 ng/min/100cc forearm volume of intrabrachial bradykinin, for 5 minutes at each dose. Forearm blood flow will be measured by strain gauge plethysmography, blood samples will be obtained to measure t-PA, PAI-1 at each dose. FMD and Radial artery tonometry will also be performed under resting conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults 18 years and greater who have undergone heart transplantation
- Healthy
Key exclusion criteria (15 listed)
- PVC < 30
- Hypertensive subjects on ACE inhibitors
- Pregnant or nursing mothers
- Diabetic with HbA1C > 7.5 or stigmata of end organ damage (neuropathy, retinopathy, nephropathy, cardiomyopathy)
- Cholesterol > 30 mg/dL above NCEP accepted level based on cardiac risk.
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 |
|---|---|---|
| BradykininPatients receive 0, 10, 20, and 40 ng/100cc forearm volume/min of bradykinin intrabrachial. | Drug | Bradykinin |
Primary outcome
Peak t-PA release
Time frame: Single Study Visit
1 secondary outcome
t-PA release at various doses
Time frame: Single Study Visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2016.
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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.
James AS Muldowney, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bradykinin in people with Heart Transplantation, run by Vanderbilt University 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 2 inclusion and 15 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: withdrawn, as of the sponsor's last update on 15 Jul 2016. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Peak t-PA release (time frame: Single Study Visit). 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 15 Jul 2016.