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Completed

NCT Number: NCT03185832

Heart Failure and Sudden Cardiac Death Japan Registry

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.

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Key information

Conditions

Heart Failure Arrhythmias, Cardiac Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Death

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ichinomiya Municipal Hospital, Ichinomiya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CRT-D

Device

This subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities

ICD

Device

This subject cohort is made by all patients enrolled and implanted with defibrillator capabilities

PM / CRT-P

Device

This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities

Non-device

Other

Patient enrolled but not implanted with a Defibrillator or Pacemaker

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

Secondary outcomes

  1. Number of Participant Deaths - ICD/CRT-D Cohorts

    Time frame: 12 months follow up

    All-cause mortality for the ICD and the CRT-D cohorts.

  2. Number of Participants With Composite HF Event - ICD/CRT-D/Pacing Cohorts

    Time frame: 12 months follow up

    Number of Participants with HF events, which require intravenous (IV) treatment and/or heart failure (HF) related hospitalization, or which led to HF death

  3. Number of Participants With Complication - ICD/CRT-D/Pacing Cohorts

    Time frame: 12 months follow up

    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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Collaborators

  • ICON Clinical Research

Registry information

Official study title

Heart Failure Indication and Sudden Cardiac Death Prevention Trial Japan

Acronym: HINODE

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 14, 2017
Registry last updated
Feb 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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