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ThalassemiaNCT00520559

T2* in Transfusion Dependant Anemia, MI, LVF, Normal Patients

An observational study of Thalassemia, run by Imperial College London.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to provide accurate prognostic data linking cardiac complications to myocardial T2* values (A measure of iron levels in the heart using MRI)in patients predisposed to heart iron overload. Read more about this study

Who is it for?
Ages 18 to 77 yearsHealthy volunteers can take part
Conditions the study is for
Thalassemia
How many people
652 participants
Where
No sites listed yet
Study dates
Jan 2007to Aug 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 to 77 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Please note that the age range detailed above refers to the normal group (63 patients): the study article provided by the study team to complete this record only provides a mean age range for the 39 Left Ventricular Dysfunction Group (50.1 +/- 14.0 years) and 24 Septal Infarction Group (58.6 +/- 13.9).

Who may be able to join

  • Thalassaemia Major
  • Patient must have had a cardiac MRI scan between 1999 and 2006

Who cannot join

  • Other structural heart disease such as valvular abnormalities, MI, congenital heart disease

About this study

Official title: Incidence of Cardiac Complications in Patients With Cardiac Siderosis During 1 Year Follow-up and the Normal T2* Ranges in LVF, MI and Normal Population.

The purpose of this study is to provide accurate prognostic data linking cardiac complications to myocardial T2* values (A measure of iron levels in the heart using MRI)in patients predisposed to heart iron overload.

Read the detailed description

Key Definitions Myocardial siderosis - Iron deposition that occurs in the heart, usually in relation to recurrent blood transfusions and red cell breakdown.

Thalassaemia - A hereditary form of anaemia leading to recurrent blood transfusions and iron overload.

Cardiomyopathy - Disease of the heart leading to heart failure. In the case of cardiac siderosis it is entirely reversible.

Chelation - Drug used to remove iron from the heart T2* CMR - Cardiac Magnetic Resonance Imaging. A specialised scan that uses a large magnet to image the heart. As iron has magnetic properties we can use this scan to determine the amount of iron within the heart. T2* is a value that relates to the level of iron loading in the heart. A T2* of less than 10 relates to severe heart iron loading, a T2* of 10-20 relates to mild/moderate heart iron loading and a T2* of greater than 20 relates to no significant iron loading in the heart.

Heart failure - Disease in which the myocardium (heart muscle) weakens and can not pump blood efficiently. Fluid accumulates in the lungs, hands, ankles, or other parts of the body. The mortality from heart failure is very high.

Heterozygotes - An individual with one normal and one abnormal thalassaemia gene. They are carriers of the thalassaemia gene with milder clinical manifestations.

Homozygotes - An individual who has inherited both abnormal thalassaemia genes producing a more severe form of the disease.

Question Response Although a rare disease in the UK, thalassaemia is the commonest genetic disorder worldwide, with approximately 94 million heterozygotes for beta thalassaemia and 60,000 homozygotes born each year.

In the United Kingdom, despite relatively easy access to healthcare, approximately 50% of patients with thalassaemia major die before reaching the age of thirty five. Of those deaths, over 60% are a result of heart failure. The cardiomyopathy is reversible if chelation is commenced early but diagnosis is often delayed due to the late onset of symptoms and measurable LV dysfunction.

This study will provide strong evidence that a myocardial T2* <10ms represents a high risk of developing cardiac complications. Derived risk ratios will provide sound guidance as to when life saving chelation is required.

A database will be produced containing clinical data and T2* values on 665 thalassaemia patients from 1998-2006.

A diagnosis of heart failure will be made if the patient has had an ejection fraction of less than 55% (measured by CMR or echocardiography) and symptoms as per NHYA classification within 1 year of their CMR scan.

A diagnosis of arrhythmia was made if the patient had documented ECG evidence within 1 year of their CMR scan.

This information will be gathered retrospectively by access to outpatient clinic letters, hospital notes, CMR/ echo reports and clinical details recorded in a proforma at the time of the CMR scan. Some of the clinical data would be obtained from other hospitals.

Patient scans will only be used if between the dates of 1999-2005. As all other data is in respect to the year immediately post scan then no further data will be required on any patient post 2006.

Logistic regression will be used to determine whether T2* is predictive of cardiac complications in the 12 months after a patient's CMR scan. Since some patients will have more than 1 scan, a mixed model logistic regression will be used to take account of any within-patient correlation that may occur.

The data will be analysed by Dr Michael Roughton (Medical Statistician, Royal Brompton Hospital)

The results will be disseminated through peer review journals

Conditions
Thalassemia
Medical subject headings
Thalassemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00520559
Study groupRoleWhat they receive
ThalassemiaNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart Failure

    Ejection fraction

    Measured: 1yr

  2. Arrhythmia

    ECG

    Measured: 1yr

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2007 (estimated)
  2. Study startJan 2007
  3. Study completionAug 2007

Resources

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
Cohort
Time perspective
Prospective
Enrolment
652 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00520559
Sponsor's protocol ID
07/MRE04/32
Status last verified
Feb 2024
First submitted
23 Aug 2007
Last updated
14 Feb 2024
Results posted
No
Data monitoring committee
No

Publications

  • Kirk P, Roughton M, Porter JB, Walker JM, Tanner MA, Patel J, Wu D, Taylor J, Westwood MA, Anderson LJ, Pennell DJ. Cardiac T2* magnetic resonance for prediction of cardiac complications in thalassemia major. Circulation. 2009 Nov 17;120(20):1961-8. doi: 10.1161/CIRCULATIONAHA.109.874487. Epub 2009 Oct 2.

    PubMed 19801505
  • Kirk P, Sheppard M, Carpenter JP, Anderson L, He T, St Pierre T, Galanello R, Catani G, Wood J, Fucharoen S, Porter JB, Walker JM, Forni GL, Pennell DJ. Post-mortem study of the association between cardiac iron and fibrosis in transfusion dependent anaemia. J Cardiovasc Magn Reson. 2017 Mar 27;19(1):36. doi: 10.1186/s12968-017-0349-3.

    PubMed 28343449
  • Kirk P, He T, Anderson LJ, Roughton M, Tanner MA, Lam WW, Au WY, Chu WC, Chan G, Galanello R, Matta G, Fogel M, Cohen AR, Tan RS, Chen K, Ng I, Lai A, Fucharoen S, Laothamata J, Chuncharunee S, Jongjirasiri S, Firmin DN, Smith GC, Pennell DJ. International reproducibility of single breathhold T2* MR for cardiac and liver iron assessment among five thalassemia centers. J Magn Reson Imaging. 2010 Aug;32(2):315-9. doi: 10.1002/jmri.22245.

    PubMed 20677256

Questions about this trial

What is this clinical trial studying?

An observational study of Thalassemia, run by Imperial College London.

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 2 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 14 Feb 2024. 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.

What does the primary outcome measure?

Heart Failure (time frame: 1yr). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00520559, which also lists 3 linked publications.

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 14 Feb 2024.

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