Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT03607669
Eligibility 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),
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03607669
Study Brief:
Protocol Section:
NCT03607669