A multicentre trial to find out whether imaging can be used to see whether heart failure patients will benefit from a device to regulate their heart
- Conditions
- Heart failureMedDRA version: 20.1Level: LLTClassification code 10064081Term: Heart failure NYHA class IIISystem Organ Class: 100000004849MedDRA version: 20.1Level: LLTClassification code 10064080Term: Heart failure NYHA class IISystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2015-001464-19-DK
- Lead Sponsor
- GE Healthcare Ltd. and its affiliates
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2001
(1) Patients =18 years of age at the time dated informed consent is obtained.
(2) Female patients must be pre-menarchal, surgically sterile (had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or, if of childbearing potential, a serum or urine pregnancy test with the results known prior to AdreView™ (Iobenguane I123 Injection) administration is negative.
(3) Patients willing and able to comply with all study procedures and a signed and dated informed consent is obtained before any study-procedure is carried out.
(4) Heart failure NYHA class II or III for symptoms, patients with ischemic or nonischemic heart disease, eligible for ICD implantation as per each site’s standard of practice.
(5) Non-ischemic dilated cardiomyopathy or ischemic heart disease of at least 3 months duration receiving guideline-directed optimal medical therapy.
(6) 25%=LVEF=35%, performed within 3 months before or at time of enrolment, as measured by radionuclide ventriculography, or electrocardiogram [ECG]-gated SPECT myocardial perfusion imaging [MPI], or magnetic resonance imaging [MR], computed tomography [CT], or 3D or 2D echocardiography [Simpson’s or multidisc method or equivalent only, M-mode echocardiography is not accepted].
In case LVEF measurement is performed within 3 months before enrolment, measurement should be performed at least 40 days after a hospitalisation for HF or acute coronary syndrome (including myocardial infarction), and to be valid, method of measurement should be in accordance with the protocol and the imaging exam should be made available to the Sponsor in digital format.
In case several valid LVEF measurements are available, the closest to enrolment will be used for inclusion determination.
(7) Clinically stable HF in the medical judgment of the investigator (i.e., no significant changes in medication, no worsening of symptoms, no unscheduled visits to the doctor’s office) for the past 30 days and no hospitalisation for HF or acute coronary syndrome (including myocardial infarction) in the past 40 days.
(8) Reasonable expectation of meaningful survival for at least 1 year.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 681
(1) Patients with existing ICD or patient having an indication of ICD implantation for secondary prevention of SCD.
(2) Hospitalisation for HF or for acute coronary syndrome in the previous 40 days.
(3) Patients where a cardiac resynchronisation therapy (CRT) is planned or indicated
(4) Other indication for placement of device (sustained ventricular tachycardia, resuscitated sudden death, need for atrioventricular pacing).
(5) NYHA class I or class IV symptoms at the time of study entry.
(6) American College of Cardiology-American Heart Association (ACC-AHA) class III or class IV (unstable) angina.
(7) Patient with chronic renal insufficiency defined as serum creatinine =3 mg/dl (or =265.2 µmol/L).
(8) Known or suspected hypersensitivity/allergy to Iobenguane or to any of the excipients in AdreView™ (Iobenguane I123 Injection).
(9) Patient who is pregnant or plans to become pregnant within 2 weeks after AdreView™ (Iobenguane I123 Injection) administration.
(10) Patient who has used any medication in the 2 weeks before AdreView™ (Iobenguane I123 Injection) that could interfere with the test: e.g., but not limited to amitriptyline or derivatives, imipramine or derivatives, other antidepressants or drugs known or suspected to inhibit the norepinephrine transporter, antihypertensives that deplete norepinephrine stores or inhibit reuptake, sympathomimetic amines or cocaine.
(11) Patients that have a medical condition that could interfere with the AdreView™ test (e.g., but not limited to left ventricular assist device, or prior heart transplant).
(12) Patients who participated in a clinical study involving a drug or device within 30 days prior to study entry and patients participating in any other clinical study.
(13) Patients having serious non-cardiac medical condition associated with significant elevation of plasma catecholamines, including pheochromocytoma.
(14) Patients with a clinical diagnosis of (or being treated for) Parkinson’s disease or Multiple System Atrophy.
(15) The patient has participated in a research study using ionizing radiation in the previous 12 months.
(16) Patients previously randomized in this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method