Heart TransplantationP1A4DNCT00780377
Intracoronary Bradykinin Mediated 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
Heart transplant recipients do not have nerves to their hearts. This protocol tests the hypothesis that bradykinin mediated t-PA release in the coronary arteries will be reduced in heart transplant recipients compared to healthy subjects. 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
- Heart transplant recipients undergoing annual cardiac catheterization who have participated our protocol: 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). (IRB # 070517)
- 25 Subjects will have transplant vasculopathy and 25 subjects will be free of transplant vasculopathy, as documented in previous angiograms.
- Otherwise 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
Show all 16Show fewer
- 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
- Healthy controls are being enrolled in SCCOR Project 1, Aims 3A and 3B (IRB# 030473 and 061160) and will not be participating under this IRB number.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: The Effects of Cardiac Innervation on Intra-coronary t-PA Release
Heart transplant recipients do not have nerves to their hearts. This protocol tests the hypothesis that bradykinin mediated t-PA release in the coronary arteries will be reduced in heart transplant recipients compared to healthy subjects.
This study will compare heart transplant recipients to healthy controls who are undergoing cardiac cath for standard of care purposes (separate protocol) and compare the coronary arteries to the forearm in transplant recipients (separate protocol) and healthy controls (separate protocol).
- Conditions
- Heart Transplantation
- Being tested
- Bradykinin
- Keywords
- Heart Transplant, Fibrinolysis, Resting conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BradykininDrug
Bradykinin 0, 0.2, 0.6, 2.0 ug/min intracoronary, for 5 minutes at each dose.
| Study group | Role | What they receive |
|---|---|---|
| Bradykinin | Experimental | Patients have holter monitoring. Patients receive intracoronary bradykinin (0.2, 0.6, 2.0 ug/min) and have coronary sinus and coronary artery blood sampling for t-PA and O2 content. Receives: Drug: Bradykinin |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-PA release in the coronary artery bed.
Measured: Single Study Visit
Secondary outcomes (2)
Heart rate variability
Measured: Single study visit
Histopathology for arteriolar t-PA and sympathetic neurons
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: Unable to perform study due to unavailable drug, then unable to partner with cath lab
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
- Not applicable
- 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 Medical Center
- Investigators
- James A S AS Muldowney, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780377
- Sponsor's protocol ID
- 080823
- Acronym
- P1A4D
- Status last verified
- Mar 2017
- First submitted
- 24 Oct 2008
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cardiac Innervation on Intra-coronary t-PA Release
- ClinicalTrials.gov ID
- NCT00780377
- Acronym / sponsor ID
- P1A4D / 080823
- Conditions
- Heart Transplantation
- Keywords
- Heart Transplant, Fibrinolysis, Resting conditions
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to perform study due to unavailable drug, then unable to partner with cath lab
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Oct 2008 (actual)
- 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.
Heart transplant recipients do not have nerves to their hearts. This protocol tests the hypothesis that bradykinin mediated t-PA release in the coronary arteries will be reduced in heart transplant recipients compared to healthy subjects.
This study will compare heart transplant recipients to healthy controls who are undergoing cardiac cath for standard of care purposes (separate protocol) and compare the coronary arteries to the forearm in transplant recipients (separate protocol) and healthy controls (separate protocol).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bradykinin | Experimental | Drug: BradykininPatients have holter monitoring. Patients receive intracoronary bradykinin (0.2, 0.6, 2.0 ug/min) and have coronary sinus and coronary artery blood sampling for t-PA and O2 content. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Heart transplant recipients undergoing annual cardiac catheterization who have participated our protocol: 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). (IRB # 070517)
- 25 Subjects will have transplant vasculopathy and 25 subjects will be free of transplant vasculopathy, as documented in previous angiograms.
- Otherwise healthy
Key exclusion criteria (16 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 |
|---|---|---|
| BradykininBradykinin 0, 0.2, 0.6, 2.0 ug/min intracoronary, for 5 minutes at each dose. | Drug | Bradykinin |
Primary outcome
T-PA release in the coronary artery bed.
Time frame: Single Study Visit
2 secondary outcomes
Heart rate variability
Time frame: Single study visit
Histopathology for arteriolar t-PA and sympathetic neurons
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 20 Mar 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.
James A S 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 3 inclusion and 16 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 20 Mar 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.
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?
T-PA release in the coronary artery bed. (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 20 Mar 2017.