Clinical trial NCT03185832: Heart Failure and Sudden Cardiac Death Japan Registry
Official title: Heart Failure Indication and Sudden Cardiac Death Prevention Trial Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Arrhythmias, Cardiac
Sudden Cardiac Death
Keywords: Hear failure
Sudden Cardiac Death
Arrhythmia
Implanted device
ICD
CRT
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: ICON Clinical Research
First posted: 2017-06-14
Enrollment: 354
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 Implantable Cardioverter-Defibrillator (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-Defibrillator (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 Pacing (PM/CRT-P) patient cohort.

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


Eligibility 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 Clinical Investigation Plan (CIP)
4. 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:

1. 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
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, 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
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 pulse generator device.

Additional eligibility criteria apply to each cohort

Primary outcomes:
measure: Number of Participants With Ventricular Arrhythmia Associated Symptoms - ICD/CRT-D Cohorts
timeFrame: 12 months follow up
measure: Number of Participant Deaths - Pacing Cohort
timeFrame: 12 months follow up
measure: Number of Participant Deaths - Non-Device Cohort
timeFrame: 12 months follow up
Secondary outcomes:
measure: Number of Participant Deaths - ICD/CRT-D Cohorts
timeFrame: 12 months follow up
measure: Number of Participants With Composite HF Event - ICD/CRT-D/Pacing Cohorts
timeFrame: 12 months follow up
measure: Number of Participants With Complication - ICD/CRT-D/Pacing Cohorts
timeFrame: 12 months follow up
Other outcomes:
Locations:
city: Ichinomiya
country: Japan
facility: Ichinomiya Municipal Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Japanese Red Cross Nagoya Daini Hospital
state: Aichi
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
state: Chiba
city: Urayasu
country: Japan
facility: Juntendo University Urayasu Hospital
state: Chiba
city: Kasuga
country: Japan
facility: Fukuoka Tokushukai Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
state: Hokkaido
city: Amagasaki
country: Japan
facility: Kansai Rosai Hospital
state: Hyogo
city: Himeji
country: Japan
facility: Hyogo Brain and Heart Center
state: Hyogo
city: Hitachi
country: Japan
facility: Hitachi General Hospital
state: Ibaraki
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
state: Ibaraki
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama Rosai Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama Minami Kyousai Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: St. Marianna University School of Medicine, Yokohama City Seibu Hospital
state: Kanagawa
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center Hospital
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Bunkyo
country: Japan
facility: Tokyo Medical and Dental University Medical Hospital
state: Tokyo
city: Bunkyō
country: Japan
facility: Nippon Medical School Hospital
state: Tokyo
city: Chuo
country: Japan
facility: St. Luke's International Hospital
state: Tokyo
city: Meguro
country: Japan
facility: Toho University Ohashi Medicine Center
state: Tokyo
city: Shibuya
country: Japan
facility: Tokyo Metropolitan Hiroo Hospital
state: Tokyo
city: Ōta
country: Japan
facility: Toho University Omori Medical Center
state: Tokyo
city: Ube
country: Japan
facility: Yamaguchi University Hospital
state: Yamaguchi
city: Fukuoka
country: Japan
facility: Kokura Memorial Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Sakurabashi Watanabe Hospital
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Saitama
country: Japan
facility: Jichi Medical University Saitama Medical Center
city: Saitama
country: Japan
facility: Japanese Red Cross Saitama Hospital
Study officials:
affiliation: University of Tsukuba Hospital
name: Kazutaka Aonuma, Professor
role: PRINCIPAL_INVESTIGATOR
References: