Back to resultsStudy of Anginera in Adults With a Left Ventricular Assist Device (LVAD) as Bridge to Transplant
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Anginera, a human tissue replacement therapy
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Anginera, LVAD, Transplant, Histology, LVAD implantation as a bridge to transplant
Eligibility Criteria
Inclusion Criteria: Stage D Heart Failure Patients having an LVAD implanted as a bridge to transplant. Exclusion Criteria: Biopsy proven acute myocarditis Known Giant Cell Myocarditis Known infiltrative disease, e.g. cardiac Amyloidosis, Sarcoidosis, hemochromatosis, Fabry's Disease
Sites / Locations
- Yale University School of Medicine
- University of Maryland School of Medicine
- University of Pennsylvania School of Medicine
Outcomes
Primary Outcome Measures
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
Safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00364598
Brief Title
Study of Anginera in Adults With a Left Ventricular Assist Device (LVAD) as Bridge to Transplant
Official Title
A Phase I Open Label Pilot Study to Obtain Tissue for Histological Analysis After Application of Anginera™ in Adults With A Left Ventricular Assist Device As A Bridge To Transplant
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
February 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Theregen, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Anginera, LVAD, Transplant, Histology, LVAD implantation as a bridge to transplant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Anginera, a human tissue replacement therapy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage D Heart Failure
Patients having an LVAD implanted as a bridge to transplant.
Exclusion Criteria:
Biopsy proven acute myocarditis
Known Giant Cell Myocarditis
Known infiltrative disease, e.g. cardiac Amyloidosis, Sarcoidosis, hemochromatosis, Fabry's Disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth B Margulies, M.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Y. Joseph Woo, M.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Pennsylvania School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Anginera in Adults With a Left Ventricular Assist Device (LVAD) as Bridge to Transplant
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