Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00456040
First received: April 2, 2007
Last updated: April 3, 2007
Last verified: April 2007
History of Changes
  Purpose

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.


Condition
Cardiomyopathy

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective
Official Title: Characteristics of Patients With Systemic Amyloidosis and Severe Heart Failure Being Evaluated for a Sequential Cardiac and Autologous Stem Cell Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Estimated Enrollment: 25
Study Start Date: March 2007
Estimated Study Completion Date: March 2007
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456040

Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Marc J Semigran, MD Massachusetts General Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00456040     History of Changes
Other Study ID Numbers: 2007-p-000302
Study First Received: April 2, 2007
Last Updated: April 3, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
amyloidosis
heart failure
heart transplant
stem cell transplant

Additional relevant MeSH terms:
Amyloidosis
Heart Failure
Cardiomyopathies
Proteostasis Deficiencies
 Metabolic Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013