Clinical trial NCT02656329: 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
Official title: AdreView™ Myocardial Imaging for Risk Evaluation - A Multicentre Trial to Guide ICD Implantation in NYHA Class II & III Heart Failure Patients With 25%≤LVEF≤35%
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Heart Failure
Keywords: Heart Failure (HF)
Single photon emission computer tomography scan (SPECT)
Implantable cardioverter defibrillator (ICD)
Left Ventricular ejection fraction (LVEF)
New York Health Association (NYHA)
Metaiodobenzylguanidine (mIBG)
123I-iobenguane
Heart-to-mediastinal ratio (H/M)
ADMIRE-ICD (AdreView Myocardial Imaging for Risk Evaluation - Implantable Cardioverter Defibrillator
All-cause mortality
Cardiac mortality
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Advanced Clinical, LLC
name: TFS
name: H2O Clinical LLC
name: AG Mednet Inc.
name: ICON CEAC
name: ICON Clinical
name: ABX CRO
name: TransPerfect
First posted: 2016-01-14
Enrollment: 395
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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 participants with 25%\<=left ventricular ejection fraction (LVEF)\<=35%, and in particular, for identifying participants who are at low risk for sudden cardiac death and who would not benefit, or may suffer harm, from implantation of an ICD device.


Eligibility criteria: Inclusion Criteria:

* Participants \>=18 years of age at the time dated informed consent was obtained.
* Female participants 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) was negative.
* Participants willing and able to comply with all study procedures and a signed and dated informed consent was obtained before any study-procedure was carried out.
* Heart failure NYHA class II or III for symptoms, participants 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 receiving guideline-directed optimal medical therapy.
* 25%≤LVEF≤35%, performed within 3 months before or at time of enrollment, 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 \[Simpson's or multidisc method only, M-mode echocardiography was not accepted\].

In case LVEF measurement was performed within 3 months before enrollment, measurement should be performed at least 40 days after a hospitalization 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 enrollment 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 hospitalization 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:

* Participants with existing ICD or participant having an indication of ICD implantation for secondary prevention of sudden cardiac death.
* Hospitalization for HF or for acute coronary syndrome in the previous 40 days.
* Participants where a cardiac resynchronisation therapy (CRT) was 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.
* Participants 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).
* Participant who was pregnant or plans to become pregnant within 2 weeks after AdreView (Iobenguane I-123 Injection) administration.
* Participant who had 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.
* Participants that had 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).
* Participants who participated in a clinical study involving a drug or device within 30 days prior to study entry and participants participating in any other clinical study.
* Participants having serious non-cardiac medical condition associated with significant elevation of plasma catecholamines, including pheochromocytoma.
* Participants with a clinical diagnosis of (or being treated for) Parkinson's disease or Multiple System Atrophy.
* The participant had participated in a research study using ionizing radiation in the previous 12 months.
* Participants previously randomized in this study.

Primary outcomes:
measure: All-cause Mortality
timeFrame: From randomization until the end of the follow-up period (median 304 days)
Secondary outcomes:
measure: Percentage of Participants With Events of Complications of Device: H/M >=1.6 in Full Analysis Set
timeFrame: From randomization until the end of the follow-up period (median 304 days)
measure: Percentage of Participants With Cardiac Death
timeFrame: From randomization until the end of the follow-up period (median 304 days)
measure: Percentage of Participants With Hospitalization for Cardiovascular Cause
timeFrame: From randomization until the end of the follow-up period (median 304 days)
measure: Percentage of Participants With All-Cause Hospitalization
timeFrame: From randomization until the end of the follow-up period (median 304 days)
measure: Percentage of Participants With Events (Composite of the Occurrence of Resuscitated Life-Threatening Ventricular Tachycardia, Unstable Ventricular Tachyarrhythmias, Sudden Cardiac Death [SCD] and Resuscitated Cardiac Arrest)
timeFrame: From randomization until the end of the follow-up period (median 304 days)
measure: Percentage of Participants With Syncope
timeFrame: From randomization until the end of the follow-up period (median 304 days)
measure: Percentage of Participants With Implantable Cardioverter Defibrillator (ICD) Implantation
timeFrame: From randomization until the end of the follow-up period (median 304 days)
measure: Percentage of Participants With Events of Complications of Device
timeFrame: From randomization until the end of the follow-up period (median 304 days)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Vascular Biology and Hypertension Program, University of Alabama at Birmingham
state: Alabama
city: Bakersfield
country: United States
facility: Comprehensive Cardiovascular Medical Group
state: California
city: La Mesa
country: United States
facility: Sharp Grossmont Hospital
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: West Haven
country: United States
facility: VA Connecticut Healthcare System (VACHS)
state: Connecticut
city: Newark
country: United States
facility: Cardiology Physicians PA/Red Clay Research, LLC
state: Delaware
city: Boynton Beach
country: United States
facility: Bethesda Health
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Jacksonville
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Pensacola
country: United States
facility: Cardiology Consultants
state: Florida
city: South Miami
country: United States
facility: South Miami Heart Specialists
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Scarborough
country: United States
facility: MMP ME Health Cardiology
state: Maine
city: Charlotte Hall
country: United States
facility: MedStar Shah Medical Group
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Department of Cardiology, K-14 (Henry Ford Health System)
state: Michigan
city: Saint Paul
country: United States
facility: Regions Hospital and Regions Heart Center Clinic
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: Buffalo
country: United States
facility: Advanced Cardiology Group
state: New York
city: Raleigh
country: United States
facility: WakeMed
state: North Carolina
city: Dallas
country: United States
facility: Veterans Affairs North Texas Healthcare System
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: McKinney
country: United States
facility: Texas Institute of Cardiology, PA
state: Texas
city: Victoria
country: United States
facility: Victoria Heart and Vascular Center
state: Texas
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de L'Estrie - CHUS Hopital Fleurimont
state: Quebec
city: Quebec
country: Canada
facility: Institut Universitaire De Cardiologie Et De Pneumologie De Quebec
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno Bohunice
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Hradec Kralove
country: Czechia
facility: FN Hradec Kralove
city: Liberec
country: Czechia
facility: Krajska nemocnice Liberec
city: Lochotín
country: Czechia
facility: Fakultni nemocnice Plzen
city: Praha 10
country: Czechia
facility: Fakultni nemocnice v Kralovske Vinohrady
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Usti nad Labem
country: Czechia
facility: Masarykova nemocnice v Usti nad Labem
city: Ars Laquenexy
country: France
facility: CHR Metz-Thionville - Site de Mercy
city: Clamart
country: France
facility: CH Antoine Beclere
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand, 63003 Montalembert
city: Créteil
country: France
facility: CHU Henri Mondor
city: Lille
country: France
facility: CHRU de Lille
city: Toulouse Cedex 9
country: France
facility: Hopital de Rangueil CHU Toulouse
city: Toulouse
country: France
facility: Clinique Pasteur
city: Vandoeuvre Les Nancy Cedex
country: France
facility: Hopitaux de Brabois Chu Nancy
city: Monchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH, Klinik fur Nuklearmedizin
city: Munich
country: Germany
facility: Klinik & Poliklinik fur Nuklearmedizin, LMU, Campus Grobhader
city: Budapest
country: Hungary
facility: Varosmajori Sziv es Ergyogyaszati Klinika
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Korhaz
city: Budapest
country: Hungary
facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont Kardiológia Osztály/Nuklearis Medicina Osztaly
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Nuklearis Medicina Kozpont
city: Debrecen
country: Hungary
facility: Debreceni Egyetem, Kardiologia Intezet and ScanoMed Nuclear Medicine Institute
city: Pécs
country: Hungary
facility: Coromed-SMO ft.
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria G. Martino
city: Milano
country: Italy
facility: Area Cardiologia Critica - IRCCS Centro Cardiologico Mozino
city: Moncalieri
country: Italy
facility: Ospedale Santa Croce
city: Napoli
country: Italy
facility: Azienda Ospedaliero-Universitaria Federico II Dipartimento ad Attivita Integrata di Cardiologia,Cardiochirurgia ed Emergenze Cardiovascolari
city: Novara
country: Italy
facility: Azienda Ospedaliero-Universitaria Maggiore della Carità, Dipartimento Cardiologico, Cardiologia 1
city: Pavia
country: Italy
facility: Instituti Clinici Scientifici Maugeri Spa Societa Benefit
city: Rome
country: Italy
facility: Dipartimento di Scienze Cardiovascolari, Respiratorie Neufrologiche e Geriatriche - Universita di Roma "La Sapienza"
city: Treviso
country: Italy
facility: Ospedale Santa Maria di Ca' Foncello
city: Venezia
country: Italy
facility: Venezia Mestre - Azienda ULSS 12 "Veneziana"
city: Venice
country: Italy
facility: Ospedale dell'Angelo, 30174, Venezia Mestre
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwen Gasthuis
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Breda
country: Netherlands
facility: Amphia Zickenhuis
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Katowice
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II
city: Warsaw
country: Poland
facility: Wojskowy Instytut Medyczny
city: Warsaw
country: Poland
facility: Samodzielny Publiczny Centralny Szpital Kliniczny
city: Wrocław
country: Poland
facility: Dolnośląski Szpital Specjalistyczny im. T. Marciniaka Centrum Medycyny Ratunkowej
city: El Palmar (Murcia)
country: Spain
facility: Hospital Clinico Universitario Virgen de la Arrixaca
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: León
country: Spain
facility: Hospital Universitario de Leon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Palma de Mallorca (Illes Balears)
country: Spain
facility: Hospital Universitario Son Espases
city: Salamanca
country: Spain
facility: Hospital Clínico de Salamanca
city: San Juan Alicante
country: Spain
facility: Hospital Universitario San Juan de Alicante
city: Santiago De Compostela (A Coruña)
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
Study officials:
References: