Status:
UNKNOWN
Study of Anginera in Adults With a Left Ventricular Assist Device (LVAD) as Bridge to Transplant
Lead Sponsor:
Theregen, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to obtain human heart tissue after treatment with Anginera to determine its effect on a variety of things that might indicate improvement in heart function. Patients who w...
Detailed Description
This will be a prospective, multi-center, randomized, open-label, within-patient paired design study. The primary purpose is to analyze cardiac tissue obtained after application of Anginera to adults ...
Eligibility Criteria
Inclusion
- Stage D Heart Failure
- Patients having an LVAD implanted as a bridge to transplant.
Exclusion
- Biopsy proven acute myocarditis
- Known Giant Cell Myocarditis
- Known infiltrative disease, e.g. cardiac Amyloidosis, Sarcoidosis, hemochromatosis, Fabry's Disease
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00364598
Start Date
December 1 2006
End Date
February 1 2009
Last Update
March 30 2009
Active Locations (3)
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1
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
2
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
3
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104