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Heart Failure and Sudden Cardiac Death Japan Registry (HINODE)

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ClinicalTrials.gov Identifier: NCT03185832
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : September 28, 2018
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief 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. These event rates will be compared with available published data mainly from Europe and the United States.

Selected Subject Cohorts:

  1. Selected subject cohort with criteria for SCD (without spontaneous prior ventricular sustained arrhythmia) and de novo ICD device treatment.
  2. Selected subject cohort with criteria for SCD and widely accepted standard cardiac resynchronization therapy (CRT) indication who received a de novo CRT-D device treatment.
  3. 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).
  4. 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 PM/CRT-P patient cohort.

The All-cause mortality will be assessed in the non-implanted subject cohort.


Condition or disease Intervention/treatment
Heart Failure Arrhythmias, Cardiac Sudden Cardiac Death Device: CRT-D Device: ICD Device: PM / CRT-P Other: Non-device

Study Type : Observational
Estimated Enrollment : 556 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Heart Failure Indication and Sudden Cardiac Death Prevention Trial Japan
Actual Study Start Date : July 21, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
CRT-D Cohort
Composite rate of first appropriately treated ventricular arrhythmia
Device: CRT-D
This subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities

ICD Cohort
Composite rate of first appropriately treated ventricular arrhythmia
Device: ICD
This subject cohort is made by all patients enrolled and implanted with defibrillator capabilities

PM / CRT-P Cohort
All cause mortality
Device: PM / CRT-P
This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities

Non-device Cohort
All-cause mortality in the subject cohort with 2 to 5 predefined SCD driving risk factors
Other: Non-device
Patient enrolled but not implanted with a Defibrillator or Pacemaker




Primary Outcome Measures :
  1. Composite rate of first appropriately treated ventricular arrhythmia in the Defibrillator Cohort (ICD and CRT-D Cohorts) [ Time Frame: 12 months follow up ]
    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 Arm B or C programming conditions in a study population with a majority of Japanese subjects.

  2. All-cause mortality in the PM/CRT-P Cohort [ Time Frame: 12 months follow up ]
    All-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II data)

  3. All-cause mortality in the 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


Secondary Outcome Measures :
  1. All-cause mortality in the Defibrillator Cohort (ICD and CRT-D) [ Time Frame: 12 months follow up ]
    All-cause mortality rate

  2. Composite rate of HF events in the ICD, CRT-D, and PM/CRT-P Cohorts [ Time Frame: 12 months follow up ]
    Composite rate of HF events, which require intravenous (IV) treatment and/or HF related hospitalization, or which led to HF death

  3. Comparison of rate of sudden cardiac death rate in the ICD, CRT-D, and Non-device Cohorts [ Time Frame: 12 months follow up ]
    Comparison of rate of sudden cardiac death in the non-device cohort with the rate of appropriately treated ventricular arrhythmias or sudden cardiac death in the defibrillator cohort (including ICD and CRT-D Cohorts)



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subjects enrolled in this observational registry are from the general population seen by enrolling physicians at primary care clinic.
Criteria

General Inclusion Criteria:

  1. Subject is aged 20 or above
  2. Subject is willing and capable of providing informed consent
  3. 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 CIP
  4. Measured Ejection fraction value obtained by echocardiography or equivalent method as 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, MI or revascularization, otherwise within the last 3 months prior to enrollment

And 12 lead 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:

  1. Subject is enrolled in any other concurrent study without prior written approval from 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
  2. Device implant revision is scheduled due to unstable result of an implant <45 days prior enrolment
  3. Subjects with more than 5 of the following risk factors: LVEF <35%, NYHA Class III or IV, 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
  4. Subjects with chronic renal disease with chronic BUN ≥50mg/dL or creatinine ≥2.5 mg/dL
  5. Subjects with coronary artery bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) within the past three calendar months prior to enrollment
  6. Subjects with enzyme-positive myocardial infarction within the past three calendar months prior to enrollment
  7. Subjects who are expected to survive for <1 year with good functional status
  8. Subject's physician does not allow participation
  9. 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
  10. Unwilling to sign the consent for participation
  11. Women of childbearing potential who are or might be pregnant at the time of study enrolment
  12. ICD and CRT-D cohorts: implanted with a non-BSC device system. PM/CRT-P cohorts: implanted with a non-BSC PG device.

Additional eligibility criteria apply to each cohort


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185832


Contacts
Contact: Torsten Kayser, Dr. +32 473 877020 torsten.kayser@bsci.com
Contact: Caroline Beaudoint +32 479 904163 caroline.beaudoint@basci.com

Locations
Japan
Ichinomiya Municipal Hospital Recruiting
Ichinomiya, Aichi, Japan, 491-8558
Contact: Toru Asai         
Nagoya University Hospital Active, not recruiting
Nagoya, Aichi, Japan, 466-8560
Japanese Red Cross Nagoya Daini Hospital Recruiting
Nagoya, Aichi, Japan, 466-8650
Contact: Yukihiko Yoshida         
Toho University Sakura Medical Active, not recruiting
Sakura, Chiba, Japan, 285-8741
Juntendo University Urayasu Hospital Recruiting
Urayasu, Chiba, Japan, 279-0021
Contact: Yuji Nakazato         
University of Fukui Hospital Active, not recruiting
Yoshida, Fukui, Japan, 910-1193
Fukuoka Tokushukai Medical Center Recruiting
Kasuga, Fukuoka, Japan, 816-0864
Contact: Hideki Shimomura         
Sapporo Medical University Hospital Recruiting
Sapporo, Hokkaido, Japan, 060-8543
Contact: Daigo Nagahara         
Sapporo Higashi Tokushukai Hospital Recruiting
Sapporo, Hokkaido, Japan, 065-0033
Contact: Tomoyuki Tani         
Kansai Rosai Hospital Active, not recruiting
Amagasaki, Hyogo, Japan, 660-3511
Hyogo Brain and Heart Center Recruiting
Himeji, Hyogo, Japan, 670-0981
Contact: Akira Shimane         
Hitachi General Hospital Recruiting
Hitachi, Ibaraki, Japan, 317-0077
Contact: Yutaka Eki         
University of Tsukuba Hospital Recruiting
Tsukuba, Ibaraki, Japan, 305-8576
Contact: Kazutaka Aonuma         
St. Marianna University School of Medicine Hospital Active, not recruiting
Kawasaki, Kanagawa, Japan, 216-8511
Yokohama Rosai Hospital Recruiting
Yokohama, Kanagawa, Japan, 222-0036
Contact: Shinya Kowase         
Yokohama Minami Kyosai Hospital Active, not recruiting
Yokohama, Kanagawa, Japan, 236-0037
Tohoku University Hospital Recruiting
Sendai, Miyagi, Japan, 980-8574
Contact: Makoto Nakano         
Osaka University Hospital Recruiting
Suita, Osaka, Japan, 565-0871
Contact: Yasushi Sakata         
National Cerebral and Cardiovascular Center Hospital Recruiting
Suita, Osaka, Japan, 565-8565
Contact: Kengo Kusano         
Sakurabashi Watanabe Hospital Recruiting
Ōsaka, Osaka, Japan, 530-0001
Contact: Koichi Inoue         
Osaka General Medical Center Recruiting
Ōsaka, Osaka, Japan, 558-8558
Contact: Yoshio Furukawa         
Jichi Medical University Recruiting
Shimotsuke, Tochigi, Japan, 329-0498
Contact: Tomoyuki Kabutoya         
Tokyo Medical and Dental University Hospital Active, not recruiting
Bunkyo, Tokyo, Japan, 113-8519
Nippon Medical School Recruiting
Bunkyō-Ku, Tokyo, Japan, 113-8603
Contact: Wataru Shimizu         
St. Luke's International Hospital Recruiting
Chuo Ku, Tokyo, Japan, 104-8560
Contact: Yasuhiro Yokoyama         
Toho University Ohashi Medicine Center Recruiting
Meguro, Tokyo, Japan, 153-8515
Contact: Keijiro Nakamura         
Tokyo Metropolitan Hiroo Hospital Recruiting
Shibuya, Tokyo, Japan, 150-0013
Contact: Seiji Fukamizu         
Toho University Omori Medical Center Recruiting
Ōta, Tokyo, Japan, 143-8541
Contact: Takanori Ikeda         
Yamaguchi University Hospital Recruiting
Ube, Yamaguchi, Japan, 755-8505
Contact: Yasuhiro Yoshida         
Kokura Memorial Hospital Recruiting
Fukuoka, Japan, 802-8555
Contact: Kenji Ando         
Kyushu University Hospital Recruiting
Fukuoka, Japan, 812-8582
Contact: Yasushi Mukai         
Okayama University Hospital Recruiting
Okayama, Japan, 700-8558
Contact: Nobuhiro Nishii         
Osaka Police Hospital Active, not recruiting
Osaka, Japan, 543-0035
Jichi Medical University Saitama Medical Center Recruiting
Saitama, Japan, 330-8503
Contact: Takeshi Mitsuhashi         
Japanese Red Cross Saitama Hospital Recruiting
Saitama, Japan, 330-8553
Contact: Junichi Nitta         
Sponsors and Collaborators
Boston Scientific Corporation
ICON Clinical Research
Investigators
Principal Investigator: Kazutaka Aonuma, Professor University of Tsukuba Hospital

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03185832     History of Changes
Other Study ID Numbers: C2076
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Boston Scientific Corporation:
Hear failure
Sudden Cardiac Death
Arrhythmia
Implanted device
ICD
CRT

Additional relevant MeSH terms:
Heart Failure
Death
Death, Sudden, Cardiac
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden