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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by GE Healthcare
Sponsor:
Collaborators:
TFS Trial Form Support
ICON plc
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT02656329
First received: January 7, 2016
Last updated: May 9, 2017
Last verified: May 2017

January 7, 2016
May 9, 2017
January 2016
August 2019   (Final data collection date for primary outcome measure)
All-cause mortality [ Time Frame: Mean observational time of 2.75 to 3 years ]
Same as current
Complete list of historical versions of study NCT02656329 on ClinicalTrials.gov Archive Site
  • Compare rate of hospitalisation and death related to major complications of ICD implantation and composite of rate of complications of long-term device therapy. [ Time Frame: Mean observational time of 2.75 to 3 years ]
    A composite of the rate of hospitalization and death related to major complications of device implantation and a composite of the rate of complications of long-term device therapy.
  • Cardiac death (dosed of sudden cardiac death. death due to cardiac arrhythmias, death due to heart failure, and death due to other cardiovascular causes. [ Time Frame: Mean observational time of 2.75 to 3 years ]
    Cardiac death (composed of sudden cardiac death, death due to cardiac arrhythmia, death due to heart failure, and death due to other cardiovascular causes).
  • Rate of all-cause hospitalization for cardiovascular cause. [ Time Frame: Mean observational time of 2.75 to 3 years ]
  • Composite of the occurrence of resuscitated life-threatening ventricular tachycardia, unstable ventricular tach-arrhythmias, sudden cardiac death and resuscitated cardiac arrest. [ Time Frame: Mean observational time of 2.75 to 3 years ]
    A composite of the occurrence of resuscitated life-threatening ventricular tachycardia, unstable ventricular tach-arrhythmias, sudden cardiac death and resuscitated cardiac arrest.
Same as current
Not Provided
Not Provided
 
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
AdreView™ Myocardial Imaging for Risk Evaluation - A Multicentre Trial to Guide ICD Implantation in NYHA Class II & III Heart Failure Patients With 30%≤LVEF≤35%
This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable cardioverter defibrillator (ICD) implantation, in New York Health Association (NYHA) class II and III heart failure patients with 30%≤left ventricular ejection fraction (LVEF)≤35%%, and in particular, for identifying patients who are at low risk for sudden cardiac death and who would not benefit, or may suffer harm, from implantation of an ICD device.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Heart Failure
  • Drug: Iobenguane I -123 Injection
    Iobenguane I-123 Injection, AdreView. All patients will be scheduled for an Iobenguane I-123 Injection, AdreView scan.
    Other Names:
    • AdreView
    • Iobenguane I-123 Injection
  • Device: Implantable Cardioverter Defibrillator
    In the Iobenguane I-123 Injection group, patient with H/M ratio less or equal to 1.6 will undergo ICD device implantation, while those with H/M ratio greater than or equal to 1.6 will not. All patients allocated to the SoC (control) group will undergo ICD implantation.
  • Drug: Thyroid blocking
    Patients will receive a thyroid blocking agent before the Iobenguane I-123 Injection, AdreView, scan unless medically not indicated, according to local practice.
    Other Names:
    • Potassium Iodide
    • Potassium Perchlorate
    • Lugol's Solution
  • Experimental: Arm 1- Iobenguane I-123 Injection
    Iobenguane I-123 Injection. AdreView-guided ICD. Patients will receive a thyroid blocking agent before the Iobenguane I-123 Injection, AdreView, scan unless medically not indicated, according to local practice.
    Interventions:
    • Drug: Iobenguane I -123 Injection
    • Drug: Thyroid blocking
  • Experimental: Arm 2 - Implantable Cardioverter Defibrillator
    Standard of care
    Intervention: Device: Implantable Cardioverter Defibrillator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2216
August 2019
August 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Thomas Koperniak, PhD 774-843-3908 Thomas.Koperniak@ge.com
Contact: Jay Chahal 44-1494-543915 Jay.Chahal@ge.com
United States,   Canada,   Czechia,   France,   Hungary,   Italy,   Netherlands,   Poland,   Spain
Czech Republic
 
NCT02656329
GE-122-020
2015-001464-19 ( EudraCT Number )
Yes
Not Provided
Not Provided
Not Provided
GE Healthcare
GE Healthcare
  • TFS Trial Form Support
  • ICON plc
Not Provided
GE Healthcare
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP