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

PHASE3TerminatedINTERVENTIONAL
Enrollment

395

Participants

Timeline

Start Date

December 30, 2015

Primary Completion Date

May 4, 2018

Study Completion Date

May 4, 2018

Conditions
Heart Failure
Interventions
DRUG

Iobenguane I -123 Injection

Iobenguane I-123 Injection, AdreView. All participants scheduled for an Iobenguane I-123 Injection, AdreView scan.

DEVICE

Implantable Cardioverter Defibrillator

In the Iobenguane I-123 Injection group, participants with H/M ratio less or equal to 1.6 underwent ICD device implantation, while those with H/M ratio greater than or equal to 1.6 did not undergo ICD implantation.

DRUG

Thyroid blocking

Participants received a thyroid blocking agent before the Iobenguane I-123 Injection, AdreView, scan unless medically not indicated, according to local practice.

DRUG

Iobenguane I -123 Injection

Iobenguane I-123 Injection, AdreView. All participants scheduled for an Iobenguane I-123 Injection, AdreView scan.

DEVICE

Implantable Cardioverter Defibrillator

All participants allocated to the SoC (control) group underwent ICD implantation.

Trial Locations (94)

1112

Varosmajori Sziv es Ergyogyaszati Klinika, Budapest

4032

Debreceni Egyetem, Kardiologia Intezet and ScanoMed Nuclear Medicine Institute, Debrecen

10024

Ospedale Santa Croce, Moncalieri

10467

Montefiore Medical Center, The Bronx

14203

University at Buffalo, Buffalo

14215

Advanced Cardiology Group, Buffalo

15706

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela (A Coruña)

18014

Hospital Universitario Virgen de las Nieves, Granada

19713

Cardiology Physicians PA/Red Clay Research, LLC, Newark

20138

Area Cardiologia Critica - IRCCS Centro Cardiologico Mozino, Milan

20622

MedStar Shah Medical Group, Charlotte Hall

24071

Hospital Universitario de Leon, León

27100

Instituti Clinici Scientifici Maugeri Spa Societa Benefit, Pavia

27610

WakeMed, Raleigh

28034

Hospital Universitario Ramon y Cajal, Madrid

28040

Hospital Clinico Universitario San Carlos, Madrid

28100

Azienda Ospedaliero-Universitaria Maggiore della Carità, Dipartimento Cardiologico, Cardiologia 1, Novara

29010

Hospital Universitario Virgen de la Victoria, Málaga

30120

Hospital Clinico Universitario Virgen de la Arrixaca, El Palmar (Murcia)

30174

"Venezia Mestre - Azienda ULSS 12 Veneziana", Venezia

30912

Augusta University, Augusta

31059

Hopital de Rangueil CHU Toulouse, Toulouse

31100

Ospedale Santa Maria di Ca' Foncello, Treviso

31300

Clinique Pasteur, Toulouse

32209

University of Florida Health Jacksonville, Jacksonville

32501

Cardiology Consultants, Pensacola

33136

University of Miami Hospital, Miami

33143

South Miami Heart Specialists, South Miami

33435

Bethesda Health, Boynton Beach

33606

Tampa General Hospital, Tampa

33609

University of South Florida, Tampa

35294

Vascular Biology and Hypertension Program, University of Alabama at Birmingham, Birmingham

37002

Hospital Clínico de Salamanca, Salamanca

40001

Masarykova nemocnice v Usti nad Labem, Ústí nad Labem

41063

Kliniken Maria Hilf GmbH, Klinik fur Nuklearmedizin, Mönchengladbach

46014

Hospital General Universitario de Valencia, Valencia

48202

Department of Cardiology, K-14 (Henry Ford Health System), Detroit

54511

Hopitaux de Brabois Chu Nancy, Vandœuvre-lès-Nancy

55101

Regions Hospital and Regions Heart Center Clinic, Saint Paul

57530

CHR Metz-Thionville - Site de Mercy, Ars-Laquenexy

59037

CHRU de Lille, Lille

60208

Northwestern University, Evanston

60612

Rush University Medical Center, Chicago

75071

Texas Institute of Cardiology, PA, McKinney

75216

Veterans Affairs North Texas Healthcare System, Dallas

77030

Houston Methodist Hospital, Houston

77901

Victoria Heart and Vascular Center, Victoria

80131

Azienda Ospedaliero-Universitaria Federico II Dipartimento ad Attivita Integrata di Cardiologia,Cardiochirurgia ed Emergenze Cardiovascolari, Napoli

91942

Sharp Grossmont Hospital, La Mesa

92140

CH Antoine Beclere, Clamart

93309

Comprehensive Cardiovascular Medical Group, Bakersfield

94010

CHU Henri Mondor, Créteil

98125

Azienda Ospedaliera Universitaria G. Martino, Messina

06510

Yale New Haven Hospital, New Haven

06516

VA Connecticut Healthcare System (VACHS), West Haven

04074

MMP ME Health Cardiology, Scarborough

02118

Boston Medical Center, Boston

T2N 1N4

University of Calgary, Calgary

T5H3V9

Royal Alexandra Hospital, Edmonton

N6A 5A5

London Health Sciences Centre, London

M5B 1W8

St. Michael's Hospital, Toronto

H1T 1C8

Montreal Heart Institute, Montreal

J1H 5N4

CIUSSS de L'Estrie - CHUS Hopital Fleurimont, Sherbrooke

G1V 4G5

Institut Universitaire De Cardiologie Et De Pneumologie De Quebec, Québec

625 00

Fakultni nemocnice Brno Bohunice, Brno

656 91

Fakultni nemocnice u sv. Anny v Brne, Brno

500 05

FN Hradec Kralove, Hradec Králové

460 63

Krajska nemocnice Liberec, Liberec

304 60

Fakultni nemocnice Plzen, Lochotín

100 34

Fakultni nemocnice v Kralovske Vinohrady, Prague

150 06

Fakultni nemocnice v Motole, Prague

Unknown

CHU Clermont-Ferrand, 63003 Montalembert, Clermont-Ferrand

Klinik & Poliklinik fur Nuklearmedizin, LMU, Campus Grobhader, Munich

Semmelweis Egyetem Nuklearis Medicina Kozpont, Budapest

Ospedale dell'Angelo, 30174, Venezia Mestre, Venice

Samodzielny Publiczny Centralny Szpital Kliniczny, Warsaw

H-1023

Budai Irgalmasrendi Korhaz, Budapest

H-1134

Gottsegen Gyorgy Orszagos Kardiologiai Intezet, Budapest

Magyar Honvedseg Egeszsegugyi Kozpont Kardiológia Osztály/Nuklearis Medicina Osztaly, Budapest

H-7623

Coromed-SMO ft., Pécs

00161

"Dipartimento di Scienze Cardiovascolari, Respiratorie Neufrologiche e Geriatriche - Universita di Roma La Sapienza", Rome

1091 AC

Onze Lieve Vrouwen Gasthuis, Amsterdam

1105 AZ

Academic Medical Center, Amsterdam

4818 CK

Amphia Zickenhuis, Breda

2333 ZA

Leiden University Medical Center, Leiden

6229 HX

Maastricht University Medical Center, Maastricht

15-276

Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

40-635

Samodzielny Publiczny Szpital Kliniczny Nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach, Katowice

31-202

Krakowski Szpital Specjalistyczny im. Jana Pawla II, Krakow

04-141

Wojskowy Instytut Medyczny, Warsaw

54-049

Dolnośląski Szpital Specjalistyczny im. T. Marciniaka Centrum Medycyny Ratunkowej, Wroclaw

07120

Hospital Universitario Son Espases, Palma de Mallorca (Illes Balears)

03550

Hospital Universitario San Juan de Alicante, San Juan Alicante

All Listed Sponsors
collaborator

Advanced Clinical, LLC

UNKNOWN

collaborator

TFS

UNKNOWN

collaborator

H2O Clinical LLC

INDUSTRY

collaborator

AG Mednet Inc.

UNKNOWN

collaborator

ICON CEAC

UNKNOWN

collaborator

ICON Clinical

UNKNOWN

collaborator

ABX CRO

OTHER

collaborator

TransPerfect

INDUSTRY

lead

GE Healthcare

INDUSTRY