Profitability Trial in Primary Preventive Implantable Cardioverter-defibrillator Recipients

Heart Rate Variability, Microvolt T-wave Alternans and Cardiac Magnetic Resonance Imaging Analysis in Primary Preventive ImplantablE Cardioverter-defibrillator Recipients Profitability Trial - HAPPIER Trial

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01823211

Acronym

HAPPIER

Enrollment

Registered

2013-04-04

Start date

2013-03-31

Completion date

2016-04-30

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischaemic Cardiomyopathy, Non-ischaemic Cardiomyopathy

Keywords

ICD (Implantable cardioverter-defibrillator), Heart rate variability, MTWA (Microvolt T-alternans), Magnetic resonance imaging (MRI)

Brief summary

The purpose of this study is further risk stratification of patients receiving implantable cardioverter-defibrillator in primary prevention of sudden cardiac death.

Detailed description

Current criteria for risk stratification of patients in risk of sudden cardiac death are mainly based on left ventricular ejection fraction and NYHA class. This criteria are too robust, approximately 2/3 of ICD recipients do not profit from this treatment in the following 5 years, especially those with non-ischaemic cardiomyopathy. We plan to sub-stratify this group of patients with both ischaemic and non-ischaemic cardiomyopathy by: non-linear heart rate variability analysis, microvolt T-wave alternans, QRT-T angle and character and amount of left ventricular scarring assessed by magnetic resonance imaging. Pre-implantation values will be correlated with numbers and character of ICD therapy (both anti-tachycardial pacing and ICD discharge). The results may allow to decrease the number of patients, who do not profit from ICD treatment.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* LVD (left ventricular dysfunction) d/t MI (Myocardial infarction), LVEF 30% or less, NYHA (New York Heart association class) II, III * LVD d/t MI, LVEF 30% to 35%, NYHA II, III * LVD d/t MI, LVEF 30% to 40%, NSVT, positive EP study * LVD d/t MI, LVEF 30% or less, NYHA I * NICM (non-ischaemic cardiomyopathy), LVEF 30% or less, NYHA II, III * NICM, LVEF 30% to 35%, NYHA II, III * NICM, LVEF 30% or less, NYHA I * signed informed consent

Exclusion criteria

* metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain, cannot have an MRI scan since the magnetic field may dislodge the metal * severe claustrophobia may not be able to tolerate an MRI scan * heart rhythm device in place before enrollment * atrial fibrillation in time of enrollment * ICD implantation indicated from secondary prevention of SCD (sudden cardiac death) * NYHA or CCS class IV * PCI or CABG in last 3 months * CMP/TIA in last 3 months * syncope of unknown etiology

Design outcomes

Primary

Measure	Time frame	Description
ventricular tachyarrhytmia	36 months	ventricular tachycardia equal or \> 250/min,ventricular fibrillation, arrhythmic storm

Secondary

Measure	Time frame	Description
sudden cardiac death	36-months	death in 24-hours after symptom onset

Other

Measure	Time frame	Description
all-cause mortality	36-months	mortality from both cardiovascular and non-cardiovascular cause
Cardiovascular mortality	36-months	death from strictly cardiovascular cause

Countries

Czechia

Outcome results