CardiomyopathyNCT00456040
Characteristics of Patients With Amyloidosis & Heart Failure Being Evaluated for a Heart Transplant
An observational study of Cardiomyopathy, run by Massachusetts General Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Mar 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with amyloidosis
- NYHA class III or IV heart failure
- Patients undergoing heart transplant evaluation
- Patients less than 18 years of age
Who cannot join
- Patients who have unstable pulse and blood pressure
About this study
Official title: Characteristics of Patients With Systemic Amyloidosis and Severe Heart Failure Being Evaluated for a Sequential Cardiac and Autologous Stem Cell Transplantation
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.
Read the 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.
- Conditions
- Cardiomyopathy
- Keywords
- amyloidosis, heart failure, heart transplant, stem cell transplant
- Medical subject headings
- Cardiomyopathies, Amyloidosis, Heart Failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Retrospective
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Marc J Semigran, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456040
- Sponsor's protocol ID
- 2007-p-000302
- Status last verified
- Apr 2007
- First submitted
- 2 Apr 2007
- Last updated
- 4 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Patients With Systemic Amyloidosis and Severe Heart Failure Being Evaluated for a Sequential Cardiac and Autologous Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00456040
- Acronym / sponsor ID
- 2007-p-000302
- Conditions
- Cardiomyopathy
- Keywords
- amyloidosis, heart failure, heart transplant, stem cell transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2007
- Study completion
- Mar 2007
- First posted
- 4 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with amyloidosis
- NYHA class III or IV heart failure
- Patients undergoing heart transplant evaluation
- Patients less than 18 years of age
Key exclusion criteria (1 listed)
- Patients who have unstable pulse and blood pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc J Semigran, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2007.