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

Sponsors

Lead Sponsor: University Hospital Ostrava

Collaborator: University Hospital Olomouc
Brno University Hospital

Source University Hospital Ostrava
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.

Overall Status Terminated
Start Date March 2013
Completion Date April 2016
Primary Completion Date December 2015
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
ventricular tachyarrhytmia 36 months
Secondary Outcome
Measure Time Frame
sudden cardiac death 36-months
Enrollment 50
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Healthy Volunteers: No

Overall Official
Location
Facility:
Brno University Hospital | Brno, 62500, Czech Republic
University Hospital Olomouc | Olomouc, 775 20, Czech Republic
University Hospital Ostrava | Ostrava, 70852, Czech Republic
Location Countries

Czech Republic

Verification Date

October 2016

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: ischaemic cardiomyopathy

Description: EP (Electrophysiology) study,magnetic resonance with LGE (Late gadolinium enhancement), ICD implantation

Label: non-ischaemic cardiomyopathy

Description: EP study,magnetic resonance imaging with LGE, ICD implantation

Acronym HAPPIER
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov