Brachial Artery t-PA Release in Heart Transplant Recipients

Heart Transplantation Clinical Trial

— P1A3C  

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00780637
• Other study ID #: 070517
• Status: Withdrawn
• Phase: N/A
• First received: October 24, 2008
• Last updated: July 14, 2016
• Start date: October 2008
• Est. completion date: May 2011

Study information

• Verified date: July 2016
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak t-PA release		Single Study Visit	No
Secondary	t-PA release at various doses		Single Study Visit	No