Heart FailureHINODENCT03185832
Heart Failure and Sudden Cardiac Death Japan Registry
An observational study of Heart Failure and Arrhythmias, Cardiac, run by Boston Scientific Corporation at 34 sites in Japan.
Trial summary
The purpose of this observational registry is to collect clinical events and outcome data in 4 different study populations (cohorts), with a majority of Japanese subjects, that are at risk of sudden cardiac death (SCD) and heart failure (HF) events. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure, Arrhythmias, Cardiac, Sudden Cardiac Death
- What is being tested?
- CRT-D, ICD and PM / CRT-P
- Type of treatment
- Medical device
- How many people
- 354 participants
- Where
- 34 sitesJapan
- Study dates
- 21 Jul 2017to 1 Dec 2020
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects enrolled in this observational registry are from the general population seen by enrolling physicians at primary care clinic.
General Inclusion Criteria:
- Subject is aged 20 or above
- Subject is willing and capable of providing informed consent
- Subject is willing and capable of participating in all visits associated with this study at an approved clinical study site and at the intervals defined by this Clinical Investigation Plan (CIP)
- Measured Ejection fraction value obtained by echocardiography or equivalent method as Standard of Care (SOC):
- Device cohorts: within the last 3 months prior to enrolment
- Non-device cohort: latest available within the last 12 months prior to enrollment in case there was no documented HF decompensation, myocardial infarction (MI) or revascularization, otherwise within the last 3 months prior to enrollment
And 12 lead electrocardiogram (ECG) recording available as SOC:
- Device cohorts: pre-implant ECG maximum 45 days before implant; post-implant ECG
- Non-device cohort: latest available maximum 12 months prior to enrollment and subject agrees in the data being used for this study
General Exclusion Criteria:
- Subject is enrolled in any other concurrent study without prior written approval from Boston Scientific (BSC), with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following:
- Schedule of procedures for the HINODE Study (i.e. should not cause additional or missed visits)
- HINODE Study outcome
- Conduct of the HINODE Study per Good Clinical Practice /International Standard Organization 14155:2011/local regulations as applicable
- Device implant revision is scheduled due to unstable result of an implant <45 days prior enrolment
- Subjects with more than 5 of the following risk factors: LVEF <35%, NYHA Class III or IV, left bundle branch block (LBBB) with QRS > 130 ms or QRS ≥150 ms, renal dysfunction (chronically BUN >26 mg/dL / ≥9.28 mmol/L), diabetes type I and II, chronic atrial fibrillation (permanent or persistent according to ESC Guideline 2016), prior MI, age >70 years, smoking today or during last 5 years
- Subjects with chronic renal disease with chronic BUN ≥50mg/dL or creatinine ≥2.5 mg/dL
- Subjects with coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) within the past three calendar months prior to enrollment
- Subjects with enzyme-positive myocardial infarction within the past three calendar months prior to enrollment
- Subjects who are expected to survive for <1 year with good functional status
- Subject's physician does not allow participation
- Subject is not willing and capable of participating in all testing or visits associated with this clinical study at an approved clinical study center and at the intervals defined by this CIP
- Unwilling to sign the consent for participation
- Women of childbearing potential who are or might be pregnant at the time of study enrolment
- ICD and CRT-D cohorts: implanted with a non-BSC device system. PM/CRT-P cohorts: implanted with a non-BSC pulse generator device.
Additional eligibility criteria apply to each cohort
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Japan34 sites
Kansai Rosai Hospital
Amagasaki, Hyōgo, 660-8511
Tokyo Medical and Dental University Medical Hospital
Bunkyo, Tokyo, 113-8519
Nippon Medical School Hospital
Bunkyō, Tokyo, 113-8603
St. Luke's International Hospital
Chūō, Tokyo, 104-8560
Kokura Memorial Hospital
Fukuoka, 802-8555
Kyushu University Hospital
Fukuoka, 812-8582
Hyogo Brain and Heart Center
Himeji, Hyōgo, 670-0981
Hitachi General Hospital
Hitachi, Ibaraki, 317-0077
Ichinomiya Municipal Hospital
Ichinomiya, Aichi-ken, 491-8558
Fukuoka Tokushukai Hospital
Kasuga, Fukuoka, 816-0864
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, 216-8511
Toho University Ohashi Medicine Center
Meguro City, Tokyo, 153-8515
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
Japanese Red Cross Nagoya Daini Hospital
Nagoya, Aichi-ken, 466-8650
Okayama University Hospital
Okayama, 700-8558
Sakurabashi Watanabe Hospital
Osaka, 530-0001
Osaka General Medical Center
Osaka, 558-8558
Toho University Omori Medical Center
Ōta-ku, Tokyo, 143-8541
Jichi Medical University Saitama Medical Center
Saitama, 330-8503
Japanese Red Cross Saitama Hospital
Saitama, 330-8553
Toho University Sakura Medical Center
Sakura, Chiba, 285-8741
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543
Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, 065-0033
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Tokyo Metropolitan Hiroo Hospital
Shibuya City, Tokyo, 150-0013
Jichi Medical University Hospital
Shimotsuke, Tochigi, 329-0498
National Cerebral and Cardiovascular Center Hospital
Suita, Osaka, 564-8565
Osaka University Hospital
Suita, Osaka, 565-0871
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505
Juntendo University Urayasu Hospital
Urayasu, Chiba, 279-0021
Yokohama Rosai Hospital
Yokohama, Kanagawa, 222-0036
Yokohama Minami Kyousai Hospital
Yokohama, Kanagawa, 236-0037
St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Yokohama, Kanagawa, 241-0811
About this study
Official title: Heart Failure Indication and Sudden Cardiac Death Prevention Trial Japan
The purpose of this observational registry is to collect clinical events and outcome data in 4 different study populations (cohorts), with a majority of Japanese subjects, that are at risk of sudden cardiac death (SCD) and heart failure (HF) events. These event rates will be compared with available published data mainly from Europe and the United States.
Selected Subject Cohorts:
Read more
- Selected subject cohort with criteria for SCD (without spontaneous prior ventricular sustained arrhythmia) and de novo Implantable Cardioverter-Defibrillator (ICD) device treatment.
- Selected subject cohort with criteria for SCD and widely accepted standard cardiac resynchronization therapy (CRT) indication who received a de novo CRT-Defibrillator (CRT-D) device treatment.
- Selected subject cohort who are clinically expected to require >40% right ventricular pacing with a left ventricular ejection fraction (LVEF) ≤50%, any determined New York Heart Association (NYHA) Class, and receiving pacemaker (PM) or CRT-Pacemaker (CRT-P) therapy despite previous device history (de novo, box changes, system revisions or upgrades).
- Selected subject cohort with criteria for SCD fulfilling European Society of Cardiology (ESC) ICD or CRT-D therapy guidelines (2016) with an LVEF ≤35%, having 2 to 5 predefined SCD risk factors but do not have or had have a cardiac implanted defibrillator, CRT-D, PM, or CRT-P.
The primary endpoint will report on the Composite rate of first appropriately treated ventricular arrhythmia (by anti-tachycardia pacing [ATP] or shock) or life-threatening symptoms associated to ventricular arrhythmia (defined as hemodynamic instability which requires treatment), whichever comes first under MADIT RIT Arm B or C programming conditions in a study population with a majority of Japanese subjects. This primary end point is assessed in the ICD/CRT-D implanted patient cohort.
The all-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II data) will be assessed in the Pacing (PM/CRT-P) patient cohort.
The all-cause mortality will be assessed in the non-implanted subject cohort.
- Conditions
- Heart Failure, Arrhythmias, Cardiac, Sudden Cardiac Death
- Being tested
- CRT-D, ICD, PM / CRT-P, Non-device
- Keywords
- Hear failure, Sudden Cardiac Death, Arrhythmia, Implanted device, ICD, CRT
- Medical subject headings
- Heart Failure, Arrhythmias, Cardiac, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT-DDevice
This subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities
ICDDevice
This subject cohort is made by all patients enrolled and implanted with defibrillator capabilities
PM / CRT-PDevice
This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities
Non-deviceOther
Patient enrolled but not implanted with a Defibrillator or Pacemaker
| Study group | Role | What they receive |
|---|---|---|
| CRT-D Cohort | Number of participants with first appropriately treated ventricular arrhythmia Receives: Device: CRT-D | |
| ICD Cohort | Number of participants with first appropriately treated ventricular arrhythmia Receives: Device: ICD | |
| Pacing (PM / CRT-P) Cohort | All cause mortality Receives: Device: PM / CRT-P | |
| Non-device Cohort | All-cause mortality in the subject cohort with 2 to 5 predefined SCD driving risk factors Receives: Other: Non-device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Ventricular Arrhythmia Associated Symptoms - ICD/CRT-D Cohorts
Number of Participants with first appropriately treated ventricular arrhythmia (by anti tachycardia pacing [ATP] or shock) or life-threatening symptoms associated to ventricular arrhythmia (defined as hemodynamic instability which requires treatment), whichever comes first under MADIT Arm B or C programming conditions in a study population with a majority of Japanese subjects.
Measured: 12 months follow up
Number of Participant Deaths - Pacing Cohort
All-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II data).
Measured: 12 months follow up
Number of Participant Deaths - Non-Device Cohort
All-cause mortality in the subject cohort with 2 to 5 predefined SCD driving risk factors.
Measured: 12 months follow up
Secondary outcomes (3)
Number of Participant Deaths - ICD/CRT-D Cohorts
All-cause mortality for the ICD and the CRT-D cohorts.
Measured: 12 months follow up
Number of Participants With Composite HF Event - ICD/CRT-D/Pacing Cohorts
Number of Participants with HF events, which require intravenous (IV) treatment and/or heart failure (HF) related hospitalization, or which led to HF death
Measured: 12 months follow up
Number of Participants With Complication - ICD/CRT-D/Pacing Cohorts
Complication refers to qualified serious adverse device effects (SADEs) post success implantation, such as re-implant procedure, required invasive procedure related to the device system, pacing exit block, all-cause infection, and death due to therapy failure.
Measured: 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start21 Jul 2017
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Responsible party
- Sponsor
- Investigators
- Kazutaka Aonuma, Professor, Principal investigator, University of Tsukuba Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185832
- Sponsor's protocol ID
- C2076
- Acronym
- HINODE
- Status last verified
- Feb 2022
- First submitted
- 12 Jun 2017
- Last updated
- 14 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Indication and Sudden Cardiac Death Prevention Trial Japan
- ClinicalTrials.gov ID
- NCT03185832
- Acronym / sponsor ID
- HINODE / C2076
- Conditions
- Heart Failure, Arrhythmias, Cardiac, Sudden Cardiac Death
- Keywords
- Hear failure, Sudden Cardiac Death, Arrhythmia, Implanted device, ICD, CRT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Posted 14 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational registry is to collect clinical events and outcome data in 4 different study populations (cohorts), with a majority of Japanese subjects, that are at risk of sudden cardiac death (SCD) and heart failure (HF) events. These event rates will be compared with available published data mainly from Europe and the United States.
Selected Subject Cohorts:
- Selected subject cohort with criteria for SCD (without spontaneous prior ventricular sustained arrhythmia) and de novo Implantable Cardioverter-Defibrillator (ICD) device treatment.
- Selected subject cohort with criteria for SCD and widely accepted standard cardiac resynchronization therapy (CRT) indication who received a de novo CRT-Defibrillator (CRT-D) device treatment.
- Selected subject cohort who are clinically expected to require >40% right ventricular pacing with a left ventricular ejection fraction (LVEF) ≤50%, any determined New York Heart Association (NYHA) Class, and receiving pacemaker (PM) or CRT-Pacemaker (CRT-P) therapy despite previous device history (de novo, box changes, system revisions or upgrades).
- Selected subject cohort with criteria for SCD fulfilling European Society of Cardiology (ESC) ICD or CRT-D therapy guidelines (2016) with an LVEF ≤35%, having 2 to 5 predefined SCD risk factors but do not have or had have a cardiac implanted defibrillator, CRT-D, PM, or CRT-P.
The primary endpoint will report on the Composite rate of first appropriately treated ventricular arrhythmia (by anti-tachycardia pacing [ATP] or shock) or life-threatening symptoms associated to ventricular arrhythmia (defined as hemodynamic instability which requires treatment), whichever comes first under MADIT RIT Arm B or C programming conditions in a study population with a majority of Japanese subjects. This primary end point is assessed in the ICD/CRT-D implanted patient cohort.
The all-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II data) will be assessed in the Pacing (PM/CRT-P) patient cohort.
The all-cause mortality will be assessed in the non-implanted subject cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CRT-D Cohort | – | Device: CRT-DNumber of participants with first appropriately treated ventricular arrhythmia |
| ICD Cohort | – | Device: ICDNumber of participants with first appropriately treated ventricular arrhythmia |
| Pacing (PM / CRT-P) Cohort | – | Device: PM / CRT-PAll cause mortality |
| Non-device Cohort | – | Other: Non-deviceAll-cause mortality in the subject cohort with 2 to 5 predefined SCD driving risk factors |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects enrolled in this observational registry are from the general population seen by enrolling physicians at primary care clinic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRT-DThis subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities | Device | CRT-D Cohort |
| ICDThis subject cohort is made by all patients enrolled and implanted with defibrillator capabilities | Device | ICD Cohort |
| PM / CRT-PThis subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities | Device | Pacing (PM / CRT-P) Cohort |
| Non-devicePatient enrolled but not implanted with a Defibrillator or Pacemaker | Other | Non-device Cohort |
Primary outcome
Number of Participants With Ventricular Arrhythmia Associated Symptoms - ICD/CRT-D Cohorts
Time frame: 12 months follow up
Number of Participants with first appropriately treated ventricular arrhythmia (by anti tachycardia pacing [ATP] or shock) or life-threatening symptoms associated to ventricular arrhythmia (defined as hemodynamic instability which requires treatment), whichever comes first under MADIT Arm B or C programming conditions in a study population with a majority of Japanese subjects.
Number of Participant Deaths - Pacing Cohort
Time frame: 12 months follow up
All-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II data).
Number of Participant Deaths - Non-Device Cohort
Time frame: 12 months follow up
All-cause mortality in the subject cohort with 2 to 5 predefined SCD driving risk factors.
3 secondary outcomes
Number of Participant Deaths - ICD/CRT-D Cohorts
Time frame: 12 months follow up
Number of Participants With Composite HF Event - ICD/CRT-D/Pacing Cohorts
Time frame: 12 months follow up
Number of Participants With Complication - ICD/CRT-D/Pacing Cohorts
Time frame: 12 months follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazutaka Aonuma, Professor principal investigator
University of Tsukuba Hospital
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Arrhythmias, Cardiac, run by Boston Scientific Corporation at 34 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Japan. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2022). 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?
Number of Participants With Ventricular Arrhythmia Associated Symptoms - ICD/CRT-D Cohorts (time frame: 12 months follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2022.