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
- Conditions
- Heart Failure
- Interventions
- Device: Implantable Cardioverter DefibrillatorDrug: Thyroid blocking
- Registration Number
- NCT02656329
- Lead Sponsor
- GE Healthcare
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 395
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AdreView™ Iobenguane I -123 Injection Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection). Participants with AdreView™ Heart-to-Mediastinal ratio (H/M) \<1.6 underwent Implantable Cardioverter Defibrillator (ICD) device implantation and H/M \>= 1.6 continued to receive Guideline-Directed Optimal Medical Therapy (GDMT) according to clinical standard practice. Standard of Care Iobenguane I -123 Injection Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection) and underwent ICD implantation and were followed up in accordance with internationally accepted Heart Failure (HF) guidelines. AdreView™ Implantable Cardioverter Defibrillator Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection). Participants with AdreView™ Heart-to-Mediastinal ratio (H/M) \<1.6 underwent Implantable Cardioverter Defibrillator (ICD) device implantation and H/M \>= 1.6 continued to receive Guideline-Directed Optimal Medical Therapy (GDMT) according to clinical standard practice. Standard of Care Implantable Cardioverter Defibrillator Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection) and underwent ICD implantation and were followed up in accordance with internationally accepted Heart Failure (HF) guidelines. AdreView™ Thyroid blocking Participants received 1 intravenous injection of 10 mCi (370 MBq) of AdreView™ (Iobenguane I-123 Injection). Participants with AdreView™ Heart-to-Mediastinal ratio (H/M) \<1.6 underwent Implantable Cardioverter Defibrillator (ICD) device implantation and H/M \>= 1.6 continued to receive Guideline-Directed Optimal Medical Therapy (GDMT) according to clinical standard practice.
- Primary Outcome Measures
Name Time Method All-cause Mortality From randomization until the end of the follow-up period (median 304 days) All-cause mortality included all reported deaths of participants during the study due to any cause. Percentage of participants who died due to any cause were reported.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Cardiac Death From randomization until the end of the follow-up period (median 304 days) Cardiac death composed of sudden cardiac death, death due to cardiac arrhythmia, death due to heart failure, and death due to other cardiovascular causes.
Percentage of Participants With Hospitalization for Cardiovascular Cause From randomization until the end of the follow-up period (median 304 days) Percentage of participants who were hospitalized for cardiovascular cause were reported.
Percentage of Participants With All-Cause Hospitalization From randomization until the end of the follow-up period (median 304 days) Percentage of participants with all-cause hospitalization were reported.
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) From randomization until the end of the follow-up period (median 304 days) Percentage of participants with composite events i.e occurrence of resuscitated life-threatening ventricular tachycardia, unstable ventricular tachy-arrhythmias, SCD and resuscitated cardiac arrest were reported. Participants who were alive at time of database lock (DBL) were censored at the last known-alive date.
Percentage of Participants With Events of Complications of Device: H/M >=1.6 in Full Analysis Set From randomization until the end of the follow-up period (median 304 days) Composite of the percentage of participants with events of hospitalization or death related to major complications of device implantation (i.e., need for thoracotomy, pericardiocentesis, or vascular surgery), complications of long-term device therapy (i.e., infection not leading to hospitalization, lead and/or generator removal/replacement, inappropriate shocks, explanation), and combined as 'complications of device' for participants with H/M \>=1.6. Participants who were alive at time of database lock (DBL) were censored at the last known-alive date.
Percentage of Participants With Syncope From randomization until the end of the follow-up period (median 304 days) Percentage of participants with Syncope were reported. Participants who were alive at time of DBL were censored at the last known-alive date by date of DBL.
Percentage of Participants With Implantable Cardioverter Defibrillator (ICD) Implantation From randomization until the end of the follow-up period (median 304 days) Percentage of participants with ICD implantation were reported.
Percentage of Participants With Events of Complications of Device From randomization until the end of the follow-up period (median 304 days) Composite of the percentage of participants with events of hospitalization or death related to major complications of device implantation (i.e., need for thoracotomy, pericardiocentesis, or vascular surgery), complications of long-term device therapy (i.e., infection not leading to hospitalization, lead and/or generator removal/replacement, inappropriate shocks, explanation), and combined as 'complications of device'.
Trial Locations
- Locations (94)
CIUSSS de L'Estrie - CHUS Hopital Fleurimont
🇨🇦Sherbrooke, Quebec, Canada
Comprehensive Cardiovascular Medical Group
🇺🇸Bakersfield, California, United States
Sharp Grossmont Hospital
🇺🇸La Mesa, California, United States
Cardiology Physicians PA/Red Clay Research, LLC
🇺🇸Newark, Delaware, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
University at Buffalo
🇺🇸Buffalo, New York, United States
Advanced Cardiology Group
🇺🇸Buffalo, New York, United States
Veterans Affairs North Texas Healthcare System
🇺🇸Dallas, Texas, United States
WakeMed
🇺🇸Raleigh, North Carolina, United States
Texas Institute of Cardiology, PA
🇺🇸McKinney, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Victoria Heart and Vascular Center
🇺🇸Victoria, Texas, United States
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Institut Universitaire De Cardiologie Et De Pneumologie De Quebec
🇨🇦Quebec, Canada
Fakultni nemocnice u sv. Anny v Brne
🇨🇿Brno, Czechia
Fakultni nemocnice Brno Bohunice
🇨🇿Brno, Czechia
FN Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Krajska nemocnice Liberec
🇨🇿Liberec, Czechia
Fakultni nemocnice v Motole
🇨🇿Praha 5, Czechia
Fakultni nemocnice Plzen
🇨🇿Lochotín, Czechia
Fakultni nemocnice v Kralovske Vinohrady
🇨🇿Praha 10, Czechia
Masarykova nemocnice v Usti nad Labem
🇨🇿Usti nad Labem, Czechia
CH Antoine Beclere
🇫🇷Clamart, France
CHU Henri Mondor
🇫🇷Créteil, France
CHRU de Lille
🇫🇷Lille, France
Clinique Pasteur
🇫🇷Toulouse, France
Hopitaux de Brabois Chu Nancy
🇫🇷Vandoeuvre Les Nancy Cedex, France
Klinik & Poliklinik fur Nuklearmedizin, LMU, Campus Grobhader
🇩🇪Munich, Germany
Debreceni Egyetem, Kardiologia Intezet and ScanoMed Nuclear Medicine Institute
🇭🇺Debrecen, Hungary
Semmelweis Egyetem Nuklearis Medicina Kozpont
🇭🇺Budapest, Hungary
Ospedale Santa Maria di Ca' Foncello
🇮🇹Treviso, Italy
Ospedale dell'Angelo, 30174, Venezia Mestre
🇮🇹Venice, Italy
Onze Lieve Vrouwen Gasthuis
🇳🇱Amsterdam, Netherlands
Academic Medical Center
🇳🇱Amsterdam, Netherlands
Amphia Zickenhuis
🇳🇱Breda, Netherlands
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdańsk, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II
🇵🇱Krakow, Poland
Wojskowy Instytut Medyczny
🇵🇱Warsaw, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny
🇵🇱Warsaw, Poland
Dolnośląski Szpital Specjalistyczny im. T. Marciniaka Centrum Medycyny Ratunkowej
🇵🇱Wrocław, Poland
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
🇪🇸El Palmar (Murcia), Spain
Hospital Universitario de Leon
🇪🇸León, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Clinico Universitario San Carlos
🇪🇸Madrid, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Clínico de Salamanca
🇪🇸Salamanca, Spain
Hospital Universitario Son Espases
🇪🇸Palma de Mallorca (Illes Balears), Spain
Hospital Universitario San Juan de Alicante
🇪🇸San Juan Alicante, Spain
Complejo Hospitalario Universitario de Santiago
🇪🇸Santiago De Compostela (A Coruña), Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Regions Hospital and Regions Heart Center Clinic
🇺🇸Saint Paul, Minnesota, United States
Coromed-SMO ft.
🇭🇺Pécs, Hungary
Ospedale Santa Croce
🇮🇹Moncalieri, Italy
Instituti Clinici Scientifici Maugeri Spa Societa Benefit
🇮🇹Pavia, Italy
University of Calgary
🇨🇦Calgary, Alberta, Canada
Venezia Mestre - Azienda ULSS 12 "Veneziana"
🇮🇹Venezia, Italy
Leiden University Medical Center
🇳🇱Leiden, Netherlands
University of Florida Health Jacksonville
🇺🇸Jacksonville, Florida, United States
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
South Miami Heart Specialists
🇺🇸South Miami, Florida, United States
Varosmajori Sziv es Ergyogyaszati Klinika
🇭🇺Budapest, Hungary
Gottsegen Gyorgy Orszagos Kardiologiai Intezet
🇭🇺Budapest, Hungary
MMP ME Health Cardiology
🇺🇸Scarborough, Maine, United States
CHR Metz-Thionville - Site de Mercy
🇫🇷Ars Laquenexy, France
Hopital de Rangueil CHU Toulouse
🇫🇷Toulouse Cedex 9, France
Area Cardiologia Critica - IRCCS Centro Cardiologico Mozino
🇮🇹Milano, Italy
Azienda Ospedaliero-Universitaria Federico II Dipartimento ad Attivita Integrata di Cardiologia,Cardiochirurgia ed Emergenze Cardiovascolari
🇮🇹Napoli, Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità, Dipartimento Cardiologico, Cardiologia 1
🇮🇹Novara, Italy
Dipartimento di Scienze Cardiovascolari, Respiratorie Neufrologiche e Geriatriche - Universita di Roma "La Sapienza"
🇮🇹Rome, Italy
VA Connecticut Healthcare System (VACHS)
🇺🇸West Haven, Connecticut, United States
Magyar Honvedseg Egeszsegugyi Kozpont Kardiológia Osztály/Nuklearis Medicina Osztaly
🇭🇺Budapest, Hungary
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
CHU Clermont-Ferrand, 63003 Montalembert
🇫🇷Clermont-Ferrand, France
Kliniken Maria Hilf GmbH, Klinik fur Nuklearmedizin
🇩🇪Monchengladbach, Germany
Cardiology Consultants
🇺🇸Pensacola, Florida, United States
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Bialystok, Poland
Azienda Ospedaliera Universitaria G. Martino
🇮🇹Messina, Italy
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
Samodzielny Publiczny Szpital Kliniczny Nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach
🇵🇱Katowice, Poland
Bethesda Health
🇺🇸Boynton Beach, Florida, United States
MedStar Shah Medical Group
🇺🇸Charlotte Hall, Maryland, United States
Budai Irgalmasrendi Korhaz
🇭🇺Budapest, Hungary
University of South Florida
🇺🇸Tampa, Florida, United States
Department of Cardiology, K-14 (Henry Ford Health System)
🇺🇸Detroit, Michigan, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Vascular Biology and Hypertension Program, University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Miami Hospital
🇺🇸Miami, Florida, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States