Brachial Artery t-PA Release in Heart Transplant Recipients

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)

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00780637

Acronym

P1A3C

Enrollment

Registered

2008-10-27

Start date

2008-10-31

Completion date

2011-05-31

Last updated

2016-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplantation

Keywords

Heart Transplant, Endothelial Function, Fibrinolysis, Transplant recipients at baseline

Brief 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. 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.

Interventions

DRUGBradykinin

Patients receive 0, 10, 20, and 40 ng/100cc forearm volume/min of bradykinin intrabrachial.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Adults 18 years and greater who have undergone heart transplantation 2. 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

Design outcomes

Primary

Measure	Time frame
Peak t-PA release	Single Study Visit

Secondary

Measure	Time frame
t-PA release at various doses	Single Study Visit

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026