NCT00364598

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at P25-P50 for phase_1 heart-failure

Timeline
Completed

Started Dec 2006

Typical duration for phase_1 heart-failure

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

March 30, 2009

Status Verified

March 1, 2009

Enrollment Period

1.9 years

First QC Date

August 14, 2006

Last Update Submit

March 27, 2009

Conditions

Heart Failure

Keywords

AngineraLVADTransplantHistologyLVAD implantation as a bridge to transplant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Safety

Interventions

Anginera, a human tissue replacement therapyDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage D Heart Failure
  • Patients having an LVAD implanted as a bridge to transplant.

You may not qualify if:

  • Biopsy proven acute myocarditis
  • Known Giant Cell Myocarditis
  • Known infiltrative disease, e.g. cardiac Amyloidosis, Sarcoidosis, hemochromatosis, Fabry's Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Kenneth B Margulies, M.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Y. Joseph Woo, M.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 14, 2006

First Posted

August 15, 2006

Study Start

December 1, 2006

Primary Completion

November 1, 2008

Study Completion

February 1, 2009

Last Updated

March 30, 2009

Record last verified: 2009-03

Locations

US(3)