Magnetic Resonance Imaging (MRI) Assessments of the Heart and Liver Iron Load in Patients With Transfusion Induced Iron Overload - Full Text View

Magnetic Resonance Imaging (MRI) Assessments of the Heart and Liver Iron Load in Patients With Transfusion Induced Iron Overload

This study is currently recruiting participants.
Verified by Novartis, May 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00673608

Purpose

This study will evaluate the change in cardiac iron load over a 53 week period measured by MRI in 3 cohorts of patients

Condition	Intervention	Phase
Haemoglobinopathies Myelodysplastic Syndromes Post Bone Marrow Transplantation Transfusional Iron Overload	Drug: deferasirox	Phase IV

MedlinePlus related topics:

Bone Marrow Transplantation MRI Scans

Drug Information available for:

Deferasirox

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Study of Magnetic Resonance Imaging Assessment of Cardiac and Liver Iron Load in Patients With Haemoglobinopathies, Myelodysplastic Syndromes (MDS) or Post Bone Marrow Transplantation (BMT) Treated With Deferasirox. (The MILE Study)

Further study details as provided by Novartis:

Primary Outcome Measures:

Change in cardiac iron load and cardiac ejection fraction by MRI recorded at baseline and after 53 weeks. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change in ventricular ejection fraction values, ventricular volumes and masses from baseline values after 53 weeks. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	November 2007

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria

Male or female haemoglobinopathy, Myelodysplastic Syndromes or Post bone marrow transplantation patients ≥ 16 years and weighing >40kg.
Lifetime minimum of > 20 units of packed red blood cell transfusions
Normal or minimally abnormal cardiac function

Exclusion criteria

Contraindication to MRI scans.
Patients with uncontrolled high blood pressure
An organ transplant less than 3 months previously.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673608

Contacts


Contact: Novartis Basel	41 61 324 1111

Locations


Australia
		Recruiting
	Adelaide, Australia
		Recruiting
	Sydney, Australia
		Recruiting
	Brisbane, Australia
		Recruiting
	Melbourne, Australia

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis	Novartis

More Information

Study ID Numbers:	CICL670AAU01
First Received:	May 5, 2008
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00673608
Health Authority:	Australia: Therapeutic Goods Administration

Keywords provided by Novartis:

Haemoglobinopathies

Myelodysplastic Syndromes

Post bone marrow transplantation

Transfusional iron overload

cardiac iron load

Study placed in the following topic categories:

Myelodysplastic syndromes

Metabolic Diseases

Precancerous Conditions

Deferasirox

Hematologic Diseases

Myelodysplastic Syndromes

Myelodysplasia

Iron Metabolism Disorders

Preleukemia

Genetic Diseases, Inborn

Hemoglobinopathies

Iron Overload

Metabolic disorder

Bone Marrow Diseases

Hemoglobinopathy

Iron

Additional relevant MeSH terms:

Neoplasms

Pathologic Processes

Disease

Molecular Mechanisms of Pharmacological Action

Syndrome

Iron Chelating Agents

Chelating Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 24, 2008