Nashville, Tennessee 37232


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).


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.


NCT ID:

NCT00780377


Primary Contact:

Principal Investigator
James A S AS Muldowney, MD
Vanderbilt University

James Muldowney, III, MD
Phone: 615-936-1720
Email: james.muldowney@vanderbilt.edu


Backup Contact:

Email: tami.neal@vanderbilt.edu
tami neal, RN
Phone: 615-936-1931


Location Contact:

Nashville, Tennessee 37232
United States

James AS Muldowney, III, MD
Phone: 615-936-1720
Email: james.muldowney@vanderbilt.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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