Manganese-Enhanced Magnetic Resonance Imaging of the Myocardium

NCT03607669 | Completed

• 1 other identifier: AC16109
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Scanning the heart using magnetic resonance imaging (MRI) enables detailed assessment of its structure and function. MRI can give more detailed information about the heart by using a contrast 'dye' that is injected into a vein during the scan. This can highlight abnormal areas within the heart. Current contrast dyes help identify scarring within the heart, which is useful in people who have had heart attacks. The investigators plan to test new contrast dye containing manganese, which works differently to current agents. They believe it will provide unique insight into how the heart works. There are many different causes of heart problems and the investigators plan to use this new contrast agent to scan three patient groups; (i) heart disease caused by heart attacks, (ii) heart disease with abnormal thickening of the heart muscle, and (iii) heart disease where the heart becomes stretched and enlarged. Healthy volunteers will be scanned for comparison. The study will be carried out at the Royal Infirmary of Edinburgh. Adults between 18 and 65 with stable heart failure can be considered. Women who may be pregnant are unable to participate, as is anyone who has some types of metal in their body, as these people can't have an MRI scan safely. All participants will have 2 MRI scans lasting about an hour each, at least 2 days apart. Some participants will be have 4 MRI scans, over a longer time period. The investigators will also take some blood samples and record a tracing of the heart rhythm and will ensure there are no abnormal side-effects by telephone follow up. The investigators believe this new agent has potential to better measure disease in the heart, improve the ability to establish the cause of heart disease and help monitor the disease over time as well as guide future treatment for individual patients.

Conditions

Ischemic Cardiomyopathy; Dilated Cardiomyopathy; Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Myocardial calcium-handling

  Quantification of myocardial calcium handling by T1 mapping, in healthy controls, and patient groups.

  1 year

Secondary Outcomes (1)

• Myocardial infarction quantification

  1 year

Study Arms (4)

Healthy Controls

Healthy volunteers of similar age and gender

Other: Mangafodipir trisodium

Ischaemic Cardiomyopathy

Patients with ischaemic cardiomyopathy and NYHA II-III heart failure

Other: Mangafodipir trisodium

Hypertrophic Cardiomyopathy

Patients with hypertrophic cardiomyopathy and NYHA II-III heart failure

Other: Mangafodipir trisodium

Dilated Cardiomyopathy

Patients with dilated cardiomyopathy and NYHA II-III heart failure

Other: Mangafodipir trisodium

Interventions

Mangafodipir trisodium OTHER

Manganese-based MRI contrast agent

Dilated Cardiomyopathy; Healthy Controls; Hypertrophic Cardiomyopathy; Ischaemic Cardiomyopathy

Eligibility Criteria

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

Study Population

Patients attending the Edinburgh Heart Centre will be invited to participate. Inpatients and outpatients are eligible. Healthy volunteers will be invited to participate by local recruitment.

You may qualify if:

• All subjects to be entered must:
• ≥ 18 years of age
• if female, be non-pregnant as evidenced by a urine pregnancy test or post-menopausal or surgically sterile
• provide written informed consent after having received oral and written information about the study
• Healthy Volunteers
• Healthy adult with no known pre-existing medical conditions
• Ischaemic Cardiomyopathy
• Ischaemic cardiomyopathy as diagnosed by reduced LV ejection fraction (≤40%) secondary to one or more ischaemic events
• Angiographically demonstrated LMS, LAD disease, or ≥2 vessel disease
• NHYA class I-III heart failure, with stable symptoms not requiring change to diuretic therapy in the preceding month
• Dilated Cardiomyopathy
• Dilated cardiomyopathy characterised with echocardiography by reduced left ventricular systolic function with impaired systolic function (ejection fraction \<40%).
• NHYA class I-III heart failure, with stable symptoms not requiring change to diuretic therapy in the preceding month
• Hypertrophic Cardiomyopathy
• Established diagnosis of hypertrophic cardiomyopathy

You may not qualify if:

• have a positive pregnancy test
• women who are breast feeding
• received an investigational drug or device within 30 days prior to administration of Mangafodipir
• have known hypersensitivity to ondansetron or other selective serotonin 5-HT3 receptor blockers
• have a history of ongoing drug abuse or alcoholism
• have a history of torsades or prolonged QT/QTc interval
• atrioventricular block (1st, 2nd or 3rd degree)
• atrial fibrillation or flutter
• have NYHA Grade IV heart failure
• have abnormal liver function tests or a history of liver disease
• have a baseline eGFR (estimated glomerular filtration rate) of \<30 mL/min)
• have uncontrolled hypertension
• have any contraindications to MRI, including implanted devices/pacemakers
• be maintained on either a calcium channel blocker or digoxin
• known diagnosis of phaeochromocytoma

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

Queen's Medical Research Institute, University of Edinburgh

Edinburgh, Midlothian, EH16 4TJ, United Kingdom

Location

Related Publications (1)

• Spath NB, Singh T, Papanastasiou G, Baker A, Janiczek RJ, McCann GP, Dweck MR, Kershaw L, Newby DE, Semple S. Assessment of stunned and viable myocardium using manganese-enhanced MRI. Open Heart. 2021 Jun;8(1):e001646. doi: 10.1136/openhrt-2021-001646.

  PMID: 34099530 DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Cardiomyopathy, Hypertrophic

Interventions

N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• David E Newby, MD PhD

  University of Edinburgh

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: July 31, 2018
• Study Start: June 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)