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

NCT02527330 | Completed

• 1 other identifier: 102-2770A3
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Heart Failure; Iron Overload; Cardiomyopathies

Keywords

Myocardial iron deposition; T2* imaging; heart failure

Outcome Measures

Primary Outcomes (1)

• T2* Values

  12 months

Study Arms (3)

Control group

Age- and gender-matched healthy volunteers recruited as normal control group.

Other: MR T2* imaging

Stable HF group

Patients with acute HF episode with hospitalization treatment within 12 months, LVEF\>=55%

Other: MR T2* imaging

Unstable HF group

Patients with acute HF episode with hospitalization treatment within 12 months, currently LVEF\<55%.

Other: MR T2* imaging

Interventions

MR T2* imaging OTHER

Cardiac magnetic resonance imaging with T2\* imaging

Control group; Stable HF group; Unstable HF group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute HF episode with hospitalization treatment within 12 months were enrolled.

You may qualify if:

• heart failure patients diagnosed in the Keelung Chang Gung Memorial Hospital
• patients must be ≥ 20 and ≤ 70 years of age
• patients must be willing to undergo standard treatment and follow up in the Heart Failure Center
• patients must be able to give informed consent.

You may not qualify if:

• patients who are judged to be noncompliant to treatment or not accessible for follow up
• patients with contraindications to MR scanning, such as claustrophobia, cardiac pacemaker, metal implants, or unable to cooperate for MRI study due to mental status
• Severe renal function impairment (glomerular filtration rate less than 30 mL/min/1.73m2)
• pregnant or breast-feeding
• history of open-heart surgery

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Radiology, Chang Gung Memorial Hospital

Guishan, Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Heart Failure; Iron Overload; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: August 19, 2015
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 25, 2017

Record last verified: 2016-08

Locations

TW (1)