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NCT00456040 Clinical Trial

Characteristics of Patients With Amyloidosis & Heart Failure Being Evaluated for a Heart Transplant

Cardiomyopathy Clinical Trial

Official title:
Characteristics of Patients With Systemic Amyloidosis and Severe Heart Failure Being Evaluated for a Sequential Cardiac and Autologous Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00456040
Other study ID # 2007-p-000302
Secondary ID
Status Completed
Phase N/A
First received April 2, 2007
Last updated April 3, 2007
Start date March 2007
Est. completion date March 2007

Study information
Verified date April 2007
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to describe the characteristics of patients with amyloidosis and severe heart failure being evaluated for cardiac and stem cell transplantation.

Description:

Systemic amyloidosis is a progressive disease leading to organ failure and death. Treatment has improved survival with stem-cell transplantation. Unfortunately, patients with amyloidosis and severe heart failure are not eligible for stem-cell transplantation.

The average rate of survival for patients with amyloidosis who receive a heart transplant is decreased.

Previous trials have raised the possibility that survival may be increased in patients with amyloidosis, if chemotherapy and stem-cell transplantation is performed after a heart transplant.

We plan to review data of patients with amyloidosis and heart failure who were being evaluated for a heart transplant.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with amyloidosis

- NYHA class III or IV heart failure

- Patients undergoing heart transplant evaluation

- Patients less than 18 years of age

Exclusion Criteria:

- Patients who have unstable pulse and blood pressure

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Massachusetts General Hospital
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