Heart Failure Clinical Trial
— CHFIRONMROfficial title:
Evaluation of Myocardial Iron Deposition in Patients of Heart Failure Using T2* MR Imaging
Verified date | August 2016 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Heart failure from myocardial iron deposition is a severe complication for patients with
hematological disorders who need repeated blood transfusions. Increased cardiac iron content
impacts the contractility of cardiomyocytes and can also lead to myocarditis, pericarditis,
and arrhythmias. The severity of cardiac dysfunction depends on the amount of iron deposited
in the myocardium.
Cardiovascular magnetic resonance (CMR) imaging is used as noninvasive method to evaluate the
amount of iron in the heart. Myocardial T2* value has been shown to correlate well with
biopsy-derived iron concentration in the heart, and myocardial T2* values less than 20ms
(indicating elevated iron) were found to be associated with LV dysfunction and improve in
concert with LV function during recovery. The majority of the recent studies about myocardial
iron overload and the effect of iron chelation therapy were focused on patients with
transfusion-dependent hematological disorder, especially beta-thalassemia major.
The objective of this 3-year project is to evaluate myocardial iron deposition in patients
with heart failure, induced by variable causes. With myocardial T2* imaging, the
investigators will analyze the decreased signal intensity in the ventricular septum and
quantitatively acquire the T2* value as marker for myocardial iron deposition. The first year
is a cross-sectional study. The investigators aim to compare the severity of myocardial iron
deposition of normal subjects and that of stable HF patients in recovery with normal or
impaired ejection fraction (EF). Total 60 subjects will be enrolled, with 20 subjects in each
group. In the 2nd and 3rd years, the investigators plan a prospective longitudinal study of
40 subjects. Enrolled patients will be evaluated with cardiac T2* imaging at three time
points, i.e., disease onset, 6 months and one year after treatment, and will be followed up
until the end of this project (1.5~3-year follow up). In total 120 MR scans will be performed
in the 2nd and 3rd years. The presence and severity of myocardial iron deposition will be
correlated with the disease course, patient biochemistry data and clinical outcome.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. heart failure patients diagnosed in the Keelung Chang Gung Memorial Hospital 2. patients must be = 20 and = 70 years of age 3. patients must be willing to undergo standard treatment and follow up in the Heart Failure Center 4. patients must be able to give informed consent. Exclusion Criteria: 1. patients who are judged to be noncompliant to treatment or not accessible for follow up 2. patients with contraindications to MR scanning, such as claustrophobia, cardiac pacemaker, metal implants, or unable to cooperate for MRI study due to mental status 3. Severe renal function impairment (glomerular filtration rate less than 30 mL/min/1.73m2) 4. pregnant or breast-feeding 5. history of open-heart surgery |
Country | Name | City | State |
---|---|---|---|
Taiwan | Department of Radiology, Chang Gung Memorial Hospital | Guishan | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | T2* Values | 12 months |
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