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Heart FailurePhase 3ADMIRE-ICDNCT02656329

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

A Phase 3 study testing Iobenguane I -123 Injection, Implantable Cardioverter Defibrillator and Thyroid blocking in people with Heart Failure, run by GE Healthcare at 94 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Iobenguane I -123 Injection, Implantable Cardioverter Defibrillator and Thyroid blocking
Could I receive a placebo?
No, everyone receives an active treatment
How many people
395 participants
Where
94 sitesin 10 countries
Study dates
30 Dec 2015to 4 May 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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].
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

94 sites in 10 countries.

94 sites in 10 countries

United States29 sites

  • Augusta University

    Augusta, Georgia, 30912

  • Comprehensive Cardiovascular Medical Group

    Bakersfield, California, 93309

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

    Birmingham, Alabama, 35294

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Bethesda Health

    Boynton Beach, Florida, 33435

  • University at Buffalo

    Buffalo, New York, 14203

  • Advanced Cardiology Group

    Buffalo, New York, 14215

  • MedStar Shah Medical Group

    Charlotte Hall, Maryland, 20622

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Veterans Affairs North Texas Healthcare System

    Dallas, Texas, 75216

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

    Detroit, Michigan, 48202

  • Northwestern University

    Evanston, Illinois, 60208

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • University of Florida Health Jacksonville

    Jacksonville, Florida, 32209

  • Sharp Grossmont Hospital

    La Mesa, California, 91942

  • Texas Institute of Cardiology, PA

    McKinney, Texas, 75071

  • University of Miami Hospital

    Miami, Florida, 33136

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

  • Cardiology Physicians PA/Red Clay Research, LLC

    Newark, Delaware, 19713

  • Cardiology Consultants

    Pensacola, Florida, 32501

  • WakeMed

    Raleigh, North Carolina, 27610

  • Regions Hospital and Regions Heart Center Clinic

    Saint Paul, Minnesota, 55101

  • MMP ME Health Cardiology

    Scarborough, Maine, 04074

  • South Miami Heart Specialists

    South Miami, Florida, 33143

  • Tampa General Hospital

    Tampa, Florida, 33606

  • University of South Florida

    Tampa, Florida, 33609

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Victoria Heart and Vascular Center

    Victoria, Texas, 77901

  • VA Connecticut Healthcare System (VACHS)

    West Haven, Connecticut, 06516

Other trials in United States

Spain11 sites

  • Hospital Clinico Universitario Virgen de la Arrixaca

    El Palmar (Murcia), 30120

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Hospital Universitario de Leon

    León, 24071

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Clinico Universitario San Carlos

    Madrid, 28040

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario Son Espases

    Palma de Mallorca (Illes Balears), 07120

  • Hospital Clínico de Salamanca

    Salamanca, 37002

  • Hospital Universitario San Juan de Alicante

    San Juan Alicante, 03550

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela (A Coruña), 15706

  • Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

Italy10 sites

  • Azienda Ospedaliera Universitaria G. Martino

    Messina, 98125

  • Area Cardiologia Critica - IRCCS Centro Cardiologico Mozino

    Milan, 20138

  • Ospedale Santa Croce

    Moncalieri, 10024

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

    Naples, 80131

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

    Novara, 28100

  • Instituti Clinici Scientifici Maugeri Spa Societa Benefit

    Pavia, 27100

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

    Rome, 00161

  • Ospedale Santa Maria di Ca' Foncello

    Treviso, 31100

  • Venezia Mestre - Azienda ULSS 12 "Veneziana"

    Venezia, 30174

  • Ospedale dell'Angelo, 30174, Venezia Mestre

    Venice

Other trials in Italy

Czechia8 sites

  • Fakultni nemocnice Brno Bohunice

    Brno, 625 00

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91

  • FN Hradec Kralove

    Hradec Králové, 500 05

  • Krajska nemocnice Liberec

    Liberec, 460 63

  • Fakultni nemocnice Plzen

    Lochotín, 304 60

  • Fakultni nemocnice v Kralovske Vinohrady

    Prague, 100 34

  • Fakultni nemocnice v Motole

    Prague, 150 06

  • Masarykova nemocnice v Usti nad Labem

    Ústí nad Labem, 40001

Other trials in Czechia

France8 sites

  • CHR Metz-Thionville - Site de Mercy

    Ars-Laquenexy, 57530

  • CH Antoine Beclere

    Clamart, 92140

  • CHU Clermont-Ferrand, 63003 Montalembert

    Clermont-Ferrand

  • CHU Henri Mondor

    Créteil, 94010

  • CHRU de Lille

    Lille, 59037

  • Hopital de Rangueil CHU Toulouse

    Toulouse, 31059

  • Clinique Pasteur

    Toulouse, 31300

  • Hopitaux de Brabois Chu Nancy

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Canada7 sites

  • University of Calgary

    Calgary, Alberta, T2N 1N4

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H3V9

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Institut Universitaire De Cardiologie Et De Pneumologie De Quebec

    Québec, G1V 4G5

  • CIUSSS de L'Estrie - CHUS Hopital Fleurimont

    Sherbrooke, Quebec, J1H 5N4

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

Hungary7 sites

  • Varosmajori Sziv es Ergyogyaszati Klinika

    Budapest, 1112

  • Budai Irgalmasrendi Korhaz

    Budapest, H-1023

  • Gottsegen Gyorgy Orszagos Kardiologiai Intezet

    Budapest, H-1134

  • Magyar Honvedseg Egeszsegugyi Kozpont Kardiológia Osztály/Nuklearis Medicina Osztaly

    Budapest, H-1134

  • Semmelweis Egyetem Nuklearis Medicina Kozpont

    Budapest

  • Debreceni Egyetem, Kardiologia Intezet and ScanoMed Nuclear Medicine Institute

    Debrecen, 4032

  • Coromed-SMO ft.

    Pécs, H-7623

Other trials in Hungary

Poland7 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Samodzielny Publiczny Szpital Kliniczny Nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach

    Katowice, 40-635

  • Krakowski Szpital Specjalistyczny im. Jana Pawla II

    Krakow, 31-202

  • Wojskowy Instytut Medyczny

    Warsaw, 04-141

  • Samodzielny Publiczny Centralny Szpital Kliniczny

    Warsaw

  • Dolnośląski Szpital Specjalistyczny im. T. Marciniaka Centrum Medycyny Ratunkowej

    Wroclaw, 54-049

Other trials in Poland

Netherlands5 sites

  • Onze Lieve Vrouwen Gasthuis

    Amsterdam, 1091 AC

  • Academic Medical Center

    Amsterdam, 1105 AZ

  • Amphia Zickenhuis

    Breda, 4818 CK

  • Leiden University Medical Center

    Leiden, 2333 ZA

  • Maastricht University Medical Center

    Maastricht, 6229 HX

Other trials in Netherlands

Germany2 sites

  • Kliniken Maria Hilf GmbH, Klinik fur Nuklearmedizin

    Mönchengladbach, 41063

  • Klinik & Poliklinik fur Nuklearmedizin, LMU, Campus Grobhader

    Munich

Other trials in Germany

About this study

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%

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.

Conditions
Heart Failure
Being tested
Iobenguane I -123 Injection, Implantable Cardioverter Defibrillator, Thyroid blocking
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
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Iobenguane I -123 InjectionDrug

    Also called AdreView, Iobenguane I-123 Injection

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

  • Implantable Cardioverter DefibrillatorDevice

    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.

  • Thyroid blockingDrug

    Also called Potassium Iodide, Potassium Perchlorate, Lugol's Solution

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

  • Iobenguane I -123 InjectionDrug

    Also called AdreView, Iobenguane I-123 Injection

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

  • Implantable Cardioverter DefibrillatorDevice

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

Study groups in NCT02656329
Study groupRoleWhat they receive
AdreView™ExperimentalParticipants 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.
Receives: Drug: Iobenguane I -123 Injection; Device: Implantable Cardioverter Defibrillator; Drug: Thyroid blocking
Standard of CareExperimentalParticipants 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.
Receives: Drug: Iobenguane I -123 Injection; Device: Implantable Cardioverter Defibrillator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause Mortality

    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.

    Measured: From randomization until the end of the follow-up period (median 304 days)

Secondary outcomes (8)

  1. Percentage of Participants With Events of Complications of Device: H/M >=1.6 in Full Analysis Set

    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.

    Measured: From randomization until the end of the follow-up period (median 304 days)

  2. Percentage of Participants With Cardiac Death

    Cardiac death composed of sudden cardiac death, death due to cardiac arrhythmia, death due to heart failure, and death due to other cardiovascular causes.

    Measured: From randomization until the end of the follow-up period (median 304 days)

  3. Percentage of Participants With Hospitalization for Cardiovascular Cause

    Percentage of participants who were hospitalized for cardiovascular cause were reported.

    Measured: From randomization until the end of the follow-up period (median 304 days)

  4. Percentage of Participants With All-Cause Hospitalization

    Percentage of participants with all-cause hospitalization were reported.

    Measured: From randomization until the end of the follow-up period (median 304 days)

  5. 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)

    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.

    Measured: From randomization until the end of the follow-up period (median 304 days)

  6. Percentage of Participants With Syncope

    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.

    Measured: From randomization until the end of the follow-up period (median 304 days)

  7. Percentage of Participants With Implantable Cardioverter Defibrillator (ICD) Implantation

    Percentage of participants with ICD implantation were reported.

    Measured: From randomization until the end of the follow-up period (median 304 days)

  8. Percentage of Participants With Events of Complications of Device

    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'.

    Measured: From randomization until the end of the follow-up period (median 304 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2016 (estimated)
  2. Study start30 Dec 2015
  3. Primary completion4 May 2018
  4. Study completion4 May 2018

Why it stopped: Sponsor discretion (low recruitment rate)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
395 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02656329
Sponsor's protocol ID
GE-122-020
Other IDs
2015-001464-19, 2015
Acronym
ADMIRE-ICD
Status last verified
Apr 2019
First submitted
7 Jan 2016
Last updated
22 May 2019
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Iobenguane I -123 Injection, Implantable Cardioverter Defibrillator and Thyroid blocking in people with Heart Failure, run by GE Healthcare at 94 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Spain, Italy, Czechia, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause Mortality (time frame: From randomization until the end of the follow-up period (median 304 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02656329.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2019.

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ADMIRE-ICD Clinical Trial NCT02656329 | AzTrials