Evaluation of Myocardial Iron Deposition in Patients of Heart Failure Using T2* MR Imaging

NCT02527330 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2017-07-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

MR T2* imaging

Cardiac magnetic resonance imaging with T2\* imaging

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Taiwan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02527330 on ClinicalTrials.gov