International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients With Mild or Moderate Heart Failure (HF) That Benefit From Implanted Medical Device (ADMIRE-ICD)

Trial Purpose and Description

This is an event-driven Phase IIIb multicenter, randomized, clinical study to demonstrate the efficacy of AdreView imaging for appropriately guiding the decision of ICD implantation, in NYHA class II and III HF patients with between 30% and 35% and in particular, for identifying patients who are at low risk for SCD and who would not benefit, or may suffer harm, from implantation of an ICD device.

Ages: 18 years and older

Gender: Both


Eligibility Criteria

Inclusion Criteria:

  • Patients ≥18 years of age at the time dated informed consent is obtained.
  • 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 I-123 Injection) administration) is negative.
  • 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.
  • Heart failure NYHA classes II or III for symptoms, patients with ischemic or non-ischemic heart disease, eligible for ICD implantation as per each site's standard of practice.
  • Heart failure NYHA classes II or III for symptoms, patients with ischemic or non-ischemic heart disease, eligible for ICD implantation as per each site's standard of practice.
  • Non-ischemic dilated cardiomyopathy or ischemic heart disease of at least 3 months duration.
  • 30%≤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 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.

  • Clinically stable heart failure 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 heart failure or acute coronary syndrome (including myocardial infarction) in the past 40 days.
  • Reasonable expectation of meaningful survival for at least 1 year.

Exclusion Criteria:

  • Patients with existing ICD or patient having an indication of ICD implantation for secondary prevention of sudden cardiac death.
  • Hospitalisation for HF or for acute coronary syndrome in the previous 40 days.
  • Patients where a cardiac resynchronisation therapy (CRT) is planned or indicated.
  • Other indication for placement of device (sustained ventricular tachycardia, resuscitated sudden death, need for atrioventricular pacing).
  • NYHA class I or class IV symptoms at the time of study entry.
  • Patient with chronic renal insufficiency defined as serum creatinine ≥ 3 mg/dl (or 265.2 µmol/L).
  • American College of College-American Heart Association (ACC-AHA) class III or class IV (unstable) angina.
  • Known or suspected hypersensitivity/allergy to Iobenguane or to any of the excipients an Adreview (Iobenguane I-131 injection).
  • Patient who is pregnant or plans to become pregnant within 2 weeks after AdreView (Iobenguane I-123 Injection) administration.
  • Patient who has used any medication in the 2 weeks before AdreView (Iobenguane I-123 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.
  • Patients that have a medical condition that could interfere with the AdreView test (e.g. but not limited to left ventricular assist device (LVAD), or prior heart transplant).
  • 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.
  • Patients having serious non-cardiac medical condition associated with significant elevation of plasma catecholamines, including pheochromocytoma.
  • Patients with a clinical diagnosis of (or being treated for) Parkinson's disease or Multiple System Atrophy.
  • The patient has participated in a research study using ionizing radiation in the previous 12 months.
  • The patient has participated in a research study using ionizing radiation in the previous 12 months.

GE Healthcare

Dates: 04/03/2017 - 08/31/2019

Last Updated: 04/07/2017

Study HIC#: 2000020060

Get Involved

For more information about this study, contact:
Douglas W Heller
203-737-3570
douglas.heller@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

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