Manganese-Enhanced Magnetic Resonance Imaging of the Myocardium

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03607669
• Date of registration: 20/07/2018
• Prospective Registration: No
• Primary sponsor: University of Edinburgh
• Public title: Manganese-Enhanced Magnetic Resonance Imaging of the Myocardium
• Scientific title: Manganese-Enhanced Magnetic Resonance Imaging: Applications in Cardiomyopathy
• Date of first enrolment: June 1, 2018
• Target sample size: 90
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03607669
• Study type: Observational

Countries of recruitment

United Kingdom

Contacts

• Name: Nicholas B Spath, MBBS BSc

• Name: Nicholas B Spath

• Name: David E Newby, MD PhD
• Affiliation: University of Edinburgh

Key inclusion & exclusion criteria

Inclusion Criteria:

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

Additionally, cohort-specific inclusion criteria as follows:

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

- Left ventricular wall thickness =15mm in any segment

- Repolarisation abnormalities on 12-lead electrocardiogram NHYA class I-III heart
failure, with stable symptoms not requiring change to diuretic therapy in the
preceding month

Exclusion Criteria:

- 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

Additionally, cohort-specific exclusion criteria as follows:

Hypertrophic Cardiomyopathy

- Coronary artery stenosis >50% any vessel

- Previous myocardial infarction

- Previous alcohol septal ablation

- Moderate or severe aortic stenosis (mean gradient >25 mmHg, mean AVA =1.5 cm2 or peak
velocity =3 m/sec),



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dilated Cardiomyopathy

Hypertrophic Cardiomyopathy

Ischemic Cardiomyopathy

Intervention(s)

Other: Mangafodipir trisodium

Primary Outcome(s)

Myocardial calcium-handling [Time Frame: 1 year]

Secondary Outcome(s)

Myocardial infarction quantification [Time Frame: 1 year]

Secondary ID(s)

AC16109

Source(s) of Monetary Support

Please refer to primary and secondary sponsors