Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients (P1A4D)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Vanderbilt University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00780377
First received: October 24, 2008
Last updated: June 24, 2009
Last verified: June 2009
  Purpose

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).


Condition Intervention
Heart Transplantation
Drug: Bradykinin

Vanderbilt University has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Effects of Cardiac Innervation on Intra-Coronary t-PA Release

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • T-PA release in the coronary artery bed. [ Time Frame: Single Study Visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart rate variability [ Time Frame: Single study visit ] [ Designated as safety issue: No ]
  • Histopathology for arteriolar t-PA and sympathetic neurons [ Time Frame: Single Study Visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2008
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bradykinin
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.
Drug: Bradykinin
Bradykinin 0, 0.2, 0.6, 2.0 ug/min intracoronary, for 5 minutes at each dose.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. 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)
  2. 25 Subjects will have transplant vasculopathy and 25 subjects will be free of transplant vasculopathy, as documented in previous angiograms.
  3. Otherwise healthy

Exclusion criteria:

  1. PVC < 30
  2. Hypertensive subjects on ACE inhibitors
  3. Pregnant or nursing mothers
  4. Diabetic with HbA1C > 7.5 or stigmata of end organ damage (neuropathy, retinopathy, nephropathy, cardiomyopathy)
  5. Cholesterol > 30 mg/dL above NCEP accepted level based on cardiac risk.
  6. Triglycerides > 200
  7. Previously diagnosed obstructive coronary artery disease
  8. Renal insufficiency (Creatinine ≥ 1.5 mg/dl)
  9. History of cerebrovascular disease
  10. Any chronic inflammatory disease (rheumatologic, inflammatory bowel disease, etc)
  11. 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).
  12. Angiotensin converting enzyme inhibitor use
  13. Coagulopathy (INR ≥ 1.5, PTT ≥ 150% of control)
  14. Peripheral Vascular Disease
  15. 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780377

Contacts
Contact: James Muldowney, III, MD 615-936-1720 james.muldowney@vanderbilt.edu
Contact: tami neal, RN 615-936-1931 tami.neal@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: James AS Muldowney, III, MD    615-936-1720    james.muldowney@vanderbilt.edu   
Contact: Tami Neal, RN    615-936-1931    tami.neal@vanderbilt.edu   
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: James A S AS Muldowney, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: James Muldowney, M.D., F.A.C.C., Assistant Professor of Medicine, Vanderbilt University School of Medicine
ClinicalTrials.gov Identifier: NCT00780377     History of Changes
Other Study ID Numbers: 080823
Study First Received: October 24, 2008
Last Updated: June 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Heart Transplant
Fibrinolysis
Resting conditions

Additional relevant MeSH terms:
Bradykinin
Kininogens
Cardiovascular Agents
Cysteine Proteinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 27, 2014