Study of Anginera in Adults With a Left Ventricular Assist Device (LVAD) as Bridge to Transplant
- Conditions
- Heart Failure
- Registration Number
- NCT00364598
- Lead Sponsor
- Theregen, Inc.
- 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 will have a left ventricular assist device (LVAD) implanted while they wait for a donated heart will be treated with Anginera. At the time of heart transplant, their diseased heart which is removed will be analyzed by microscopic examination to see what effect Anginera had.
- 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 with an LVAD as a bridge to transplant, to determine effects on various markers.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
- Stage D Heart Failure
- Patients having an LVAD implanted as a bridge to transplant.
- Biopsy proven acute myocarditis
- Known Giant Cell Myocarditis
- Known infiltrative disease, e.g. cardiac Amyloidosis, Sarcoidosis, hemochromatosis, Fabry's Disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method To analyze cardiac tissue obtained after application of Anginera to adults with an LVAD as a bridge to transplant, to determine effects on various markers.
- Secondary Outcome Measures
Name Time Method Safety
Trial Locations
- Locations (3)
University of Pennsylvania School of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States