Heart Failure
Conditions
Keywords
Anginera, LVAD, Transplant, Histology, LVAD implantation as a bridge to transplant
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.
Interventions
Sponsors
Theregen, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety | — |
Countries
United States
Outcome results
None listed