Heart failure MedDRA version: 19.0 Level: LLT Classification code 10064081 Term: Heart failure NYHA class III System Organ Class: 100000004849 MedDRA version: 19.0 Level: LLT Classification code 10064080 Term: Heart failure NYHA class II System Organ Class: 100000004849
Conditions
Interventions
Trade Name: AdreView™
Product Name: AdreView™
Pharmaceutical Form: Solution for injection
INN or Proposed INN: [123I]iobenguane
Other de
Sponsors
GE Healthcare Ltd. and its affiliates
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (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 classes 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. (6) 30%=LVEF=35%, performed 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]. (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 1351 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 865
Exclusion criteria
Exclusion criteria: (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 enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of ICD implantation in a population of New York Heart Association (NYHA) class II and III Heart Failure (HF) patients with 30%=left ventricular ejection fraction (LVEF) =35%. This will be achieved by comparing allcause mortality observed in the AdreView™-guided therapy group to that observed in patients receiving the Standard of Care (SoC; defined as the medical care as recommended by internationally accepted HF guidelines), in whom no clinical decision will be made based upon AdreView™ scan results.; Secondary Objective: Compare the rate of hospitalisation and death related to major complications of ICD implantation and a composite of the rate of complications of long-term device therapy in patients randomised to the AdreView group with a heart-to-mediastinal ratio (H/M) =1.6 with patients in the SoC group with H/M =1.6 Compare AdreView-guided therapy to SoC therapy for: -occurrence of cardiac death -rate of hospitalisation for cardiovascular cause -rate of all-cause hospitalisation -composite of the occurrence of resuscitated life-threatening ventricular tachycardia, unstable ventricular tachy-arrhythmias, SCD and resuscitated cardiac arrest -occurrence of syncope. -clinical and healthcare resource utilisation data including ICD implantation, all hospitalisations, treatment of adverse events and AdreView administration Composite of the rate of hospitalisation and death related to major complications of device implantation and composite of the rate of complications of long-term device therapy ;Primary end point(s): The primary endpoint will be all-cause mortality;Timepoint(s) of evaluation of this end point: The duration of this study will be dependent on the time taken to achieve a total of 247 primary endpoi | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - A composite of the rate of hospitalisation and death related to major complications of device implantation (i.e., need for thoracotomy, pericardiocentesis, or vascular surgery) and a composite of the rate of complications of long-term device therapy (i.e., infection not leading to hospitalisation, lead and/or generator removal/replacement, inappropriate shocks, explantation). (AdreView™ Low-risk group vs SoC H/M =1.6) - Cardiac death (composed of SCD, death due to cardiac arrhythmia, death due to HF, and death due to other cardiovascular causes) - The rate of hospitalisation for cardiovascular cause. - The rate of all-cause hospitalisation. - A composite of the occurrence of resuscitated life-threatening ventricular tachycardia, unstable ventricular tachy-arrhythmias, SCD and resuscitated cardiac arrest. ;Timepoint(s) of evaluation of this end point: The duration of this study will be dependent on the time taken to achieve a total of 247 primary endpoint events in the randomised part of the study. The expected mean observational time per patient is 2.75 to 3 years | — |
Countries
Canada, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom, United States
Contacts
Public ContactMedical Director - Nuclear Medicine
GE Healthcare Ltd.
Outcome results
None listed