Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients

Not Applicable

Withdrawn

• Conditions: Heart Transplantation
• Interventions: Drug: Bradykinin

• Registration Number: NCT00780377
• Lead Sponsor: Vanderbilt University

Brief 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.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-24
• Study First Submitted QC: 2008-10-24
• Study First Posted: 2008-10-27
• Primary Completion: 2011-01
• Study Completion: 2011-05
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-03-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bradykinin	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.

Primary Outcome Measures

Name	Time	Method
T-PA release in the coronary artery bed.	Single Study Visit

Secondary Outcome Measures

Name	Time	Method
Heart rate variability	Single study visit
Histopathology for arteriolar t-PA and sympathetic neurons	Single Study Visit

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States