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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00456040
First Posted: April 4, 2007
Last Update Posted: April 4, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Massachusetts General Hospital
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456040


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

ClinicalTrials.gov Identifier: NCT00456040     History of Changes
Other Study ID Numbers: 2007-p-000302
First Submitted: April 2, 2007
First Posted: April 4, 2007
Last Update Posted: April 4, 2007
Last Verified: April 2007

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

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