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)
Heart Failure
About this trial
This is an interventional prevention trial for Heart Failure focused on measuring 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
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.
Sites / Locations
- Vascular Biology and Hypertension Program, University of Alabama at Birmingham
- Comprehensive Cardiovascular Medical Group
- Sharp Grossmont Hospital
- Yale New Haven Hospital
- VA Connecticut Healthcare System (VACHS)
- Cardiology Physicians PA/Red Clay Research, LLC
- Bethesda Health
- University of Florida Health Jacksonville
- University of Miami Hospital
- Cardiology Consultants
- South Miami Heart Specialists
- Tampa General Hospital
- University of South Florida
- Augusta University
- Rush University Medical Center
- Northwestern University
- MMP ME Health Cardiology
- MedStar Shah Medical Group
- Boston Medical Center
- Department of Cardiology, K-14 (Henry Ford Health System)
- Regions Hospital and Regions Heart Center Clinic
- Montefiore Medical Center
- University at Buffalo
- Advanced Cardiology Group
- WakeMed
- Veterans Affairs North Texas Healthcare System
- Houston Methodist Hospital
- Texas Institute of Cardiology, PA
- Victoria Heart and Vascular Center
- University of Calgary
- Royal Alexandra Hospital
- London Health Sciences Centre
- St. Michael's Hospital
- Montreal Heart Institute
- CIUSSS de L'Estrie - CHUS Hopital Fleurimont
- Institut Universitaire De Cardiologie Et De Pneumologie De Quebec
- Fakultni nemocnice Brno Bohunice
- Fakultni nemocnice u sv. Anny v Brne
- FN Hradec Kralove
- Krajska nemocnice Liberec
- Fakultni nemocnice Plzen
- Fakultni nemocnice v Kralovske Vinohrady
- Fakultni nemocnice v Motole
- Masarykova nemocnice v Usti nad Labem
- CHR Metz-Thionville - Site de Mercy
- CH Antoine Beclere
- CHU Clermont-Ferrand, 63003 Montalembert
- CHU Henri Mondor
- CHRU de Lille
- Hopital de Rangueil CHU Toulouse
- Clinique Pasteur
- Hopitaux de Brabois Chu Nancy
- Kliniken Maria Hilf GmbH, Klinik fur Nuklearmedizin
- Klinik & Poliklinik fur Nuklearmedizin, LMU, Campus Grobhader
- Varosmajori Sziv es Ergyogyaszati Klinika
- Budai Irgalmasrendi Korhaz
- Gottsegen Gyorgy Orszagos Kardiologiai Intezet
- Magyar Honvedseg Egeszsegugyi Kozpont Kardiológia Osztály/Nuklearis Medicina Osztaly
- Semmelweis Egyetem Nuklearis Medicina Kozpont
- Debreceni Egyetem, Kardiologia Intezet and ScanoMed Nuclear Medicine Institute
- Coromed-SMO ft.
- Azienda Ospedaliera Universitaria G. Martino
- Area Cardiologia Critica - IRCCS Centro Cardiologico Mozino
- Ospedale Santa Croce
- Azienda Ospedaliero-Universitaria Federico II Dipartimento ad Attivita Integrata di Cardiologia,Cardiochirurgia ed Emergenze Cardiovascolari
- Azienda Ospedaliero-Universitaria Maggiore della Carità, Dipartimento Cardiologico, Cardiologia 1
- Instituti Clinici Scientifici Maugeri Spa Societa Benefit
- Dipartimento di Scienze Cardiovascolari, Respiratorie Neufrologiche e Geriatriche - Universita di Roma "La Sapienza"
- Ospedale Santa Maria di Ca' Foncello
- Venezia Mestre - Azienda ULSS 12 "Veneziana"
- Ospedale dell'Angelo, 30174, Venezia Mestre
- Onze Lieve Vrouwen Gasthuis
- Academic Medical Center
- Amphia Zickenhuis
- Leiden University Medical Center
- Maastricht University Medical Center
- Uniwersytecki Szpital Kliniczny w Bialymstoku
- Uniwersyteckie Centrum Kliniczne
- Samodzielny Publiczny Szpital Kliniczny Nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach
- Krakowski Szpital Specjalistyczny im. Jana Pawla II
- Wojskowy Instytut Medyczny
- Samodzielny Publiczny Centralny Szpital Kliniczny
- Dolnośląski Szpital Specjalistyczny im. T. Marciniaka Centrum Medycyny Ratunkowej
- Hospital Clinico Universitario Virgen de la Arrixaca
- Hospital Universitario Virgen de las Nieves
- Hospital Universitario de Leon
- Hospital Universitario Ramon y Cajal
- Hospital Clinico Universitario San Carlos
- Hospital Universitario Virgen de la Victoria
- Hospital Universitario Son Espases
- Hospital Clínico de Salamanca
- Hospital Universitario San Juan de Alicante
- Complejo Hospitalario Universitario de Santiago
- Hospital General Universitario de Valencia
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
AdreView™
Standard of Care
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.
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.