Profitability Trial in Primary Preventive Implantable Cardioverter-defibrillator Recipients (HAPPIER)

October 27, 2016 updated by: University Hospital Ostrava

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

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

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic, 62500
        • Brno University Hospital
      • Olomouc, Czech Republic, 775 20
        • University Hospital Olomouc
      • Ostrava, Czech Republic, 70852
        • University Hospital Ostrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Heart-failure clinic,primary care clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ischaemic cardiomyopathy
EP (Electrophysiology) study,magnetic resonance with LGE (Late gadolinium enhancement), ICD implantation
non-ischaemic cardiomyopathy
EP study,magnetic resonance imaging with LGE, ICD implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ventricular tachyarrhytmia
Time Frame: 36 months
ventricular tachycardia equal or > 250/min,ventricular fibrillation, arrhythmic storm
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sudden cardiac death
Time Frame: 36-months
death in 24-hours after symptom onset
36-months

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Collaborators

Brno University Hospital
University Hospital Olomouc

Investigators

  • Study Director: Jiri Plasek, MD, PhD, Department of Cardiology,University hospital Ostrava
  • Study Chair: Milos Taborsky, MD, PhD, FESC, Department of Cardiology,University Hospital Olomouc
  • Principal Investigator: Lubos Krivan, MD, PhD, Department of Cardiology,University Hospital Brno-Bohunice
  • Principal Investigator: Ondrej Moravec, MD, Department of Cardiology,University Hospital Olomouc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

March 19, 2013

First Submitted That Met QC Criteria

March 28, 2013

First Posted (Estimate)

April 4, 2013

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNO-KVO-2
  • Plasek680-2 (Registry Identifier: www.happiertrial.org)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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