The aim of the current study is to improve the diagnosis of iron overload in MDS patients. The primary objectives are to evaluate 1. the relationship between red blood cell transfusions and iron overload in liver and heart as investigated by MRI T2…
ID
Source
Brief title
Condition
- Haematopoietic neoplasms (excl leukaemias and lymphomas)
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Serum iron, serum ferritin, transferrin saturation level, hepcidin, GDF15 and
sTfR.
Iron overload as assessed by MRI T2* heart and liver and left ventricular
function by echocardiography.
Secondary outcome
Not applicable.
Background summary
Title of the study:
Iron overload in MDS patients: the value of new iron parameters and MRI T2* of
heart and liver as predictor of iron overload.
Background of the study:
Patients with MDS often develop anemia and become transfusion-dependent in the
course of the disease. Frequent blood transfusions cause iron overload,
especially in the heart and the liver. Iron overload has significant clinical
consequences, including liver cirrhosis and heart failure, with increased
morbidity and mortality. Iron overload in MDS patients is mainly caused by
blood transfusions but can also be the result of an ineffective erythropoiesis.
The pathophysiological mechanisms of iron overload and subsequent organ
dysfunction are largely unknown. The occurrence of iron overload is frequently
not recognized or only at a late stage. Nowadays, prevention and treatment of
iron overload and its complications is possible by new iron chelating agents.
Study objective
The aim of the current study is to improve the diagnosis of iron overload in
MDS patients. The primary objectives are to evaluate 1. the relationship
between red blood cell transfusions and iron overload in liver and heart as
investigated by MRI T2* in MDS patients and 2. the relationship between the
iron parameters (serum ferritin and transferrin saturation level) and iron
overload as investigated by MRI T2* in blood transfusion dependent MDS
patients. The secondary objectives are to determine evidence for iron overload
in blood transfusion-dependent and independent MDS patients due to ineffective
erythropoiesis by measuring iron parameters like serum iron, serum ferritin,
transferrin saturation level, hepcidin, GDF15, sTfR and MRI T2* (liver and
heart).
Study design
The study is a prospective, multicenter, non-randomized and non-interventional
investigation.
The study is performed in 75 patients from the Radboud University Nijmegen
Medical Center and participating hospitals in the IKO and IKZ region. The
inclusion period is 3 years with 3 year follow-up for each patient. The
following investigations will be performed at inclusion and once yearly during
follow-up: MRI T2* heart and liver and echocardiography. Every six months a
blood sample of 20mL will be collected (simultaneously with regular blood
sampling) to determine specific iron parameters.
Intervention
Protocol pg. 14, 15
- MRI T2* liver: liver iron content
- MRI T2* heart: myocardial iron content and ejection fraction
- Echocardiography: evaluation of the left ventricular diastolic function
Study burden and risks
MRI and echocardiography at inclusion and once yearly during follow-up.
Theodoor Craanenlaan 1
6500 HB Nijmegen
NL
Theodoor Craanenlaan 1
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
- Patients with MDS according to WHO 2001-criteria (RA, RARS, RAEB-1, RAEB-2, RCMD, RCMD-RS, MDS with isolated del(5q), MDS-U).
- Patient with IPSS low-risk, intermediate-1 or intermediate-2 risk.
- Untreated patients or patients treated with blood transfusions, growth factors, iron chelation therapy, the immunomodulatory drug lenalidomide or the hypomethylating agents azacitidine or decitabine.
- Informed consent and of legal age at the time of obtaining informed consent (*18yrs).
Exclusion criteria
- Patients with previous intensive anti-leukemic therapy (intensive chemotherapy and/or stem cell transplantation).
- Patients with secondary or therapy-related AML and MDS after chemotherapy for a malignancy or radiotherapy.
- Patients with IPSS high risk MDS.
- Patients with a contraindication for MRI: Metal body parts, internal defibrillator, pacemaker, neurostimulator, bladder stimulator, insulin pump, cochlear implant, claustrophobia or another reason that prohibits MRI evaluation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL35915.091.11 |