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

This study is currently recruiting participants.
Verified September 2013 by University Hospital Ostrava
Sponsor:
Collaborators:
University Hospital Olomouc
Brno University Hospital
Information provided by (Responsible Party):
Vaclav Prochazka, MD, PhD. MSc, University Hospital Ostrava
ClinicalTrials.gov Identifier:
NCT01823211
First received: March 19, 2013
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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


Condition
Ischaemic Cardiomyopathy
Non-ischaemic Cardiomyopathy

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: Heart Rate Variability, Microvolt T-wave Alternans and Cardiac Magnetic Resonance Imaging Analysis in Primary Preventive ImplantablE Cardioverter-defibrillator Recipients Profitability Trial - HAPPIER Trial

Resource links provided by NLM:


Further study details as provided by University Hospital Ostrava:

Primary Outcome Measures:
  • ventricular tachyarrhytmia [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    ventricular tachycardia equal or > 250/min,ventricular fibrillation, arrhythmic storm


Secondary Outcome Measures:
  • sudden cardiac death [ Time Frame: 36-months ] [ Designated as safety issue: No ]
    death in 24-hours after symptom onset


Other Outcome Measures:
  • all-cause mortality [ Time Frame: 36-months ] [ Designated as safety issue: No ]
    mortality from both cardiovascular and non-cardiovascular cause

  • Cardiovascular mortality [ Time Frame: 36-months ] [ Designated as safety issue: No ]
    death from strictly cardiovascular cause


Estimated Enrollment: 360
Study Start Date: March 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Heart-failure clinic,primary care clinic

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01823211

Contacts
Contact: Vaclav Prochazka, MD,PhD,MSc +420597372510 vaclav.prochazka@fno.cz

Locations
Czech Republic
Brno University Hospital Recruiting
Brno, Czech Republic, 62500
Contact: Jindrich Spinar, MD,PhD,FESC    +420 532 23 2601    jspinar@fnbrno.cz   
Principal Investigator: Lubos Krivan, MD,PhD         
University Hospital Olomouc Recruiting
Olomouc, Czech Republic, 775 20
Contact: Milos Taborsky, MD,PhD,FESC,MBA    +420 588 443 201    1.interna@fnol.cz   
Principal Investigator: Ondrej Moravec, MD         
University Hospital Ostrava Recruiting
Ostrava, Czech Republic, 70852
Contact: Vaclav Prochazka, MD,PhD,MSc    +420597372510    vaclav.prochazka@fno.cz   
Principal Investigator: Jiri Plasek, MD,PhD         
Sub-Investigator: David Sipula, MD         
Sponsors and Collaborators
University Hospital Ostrava
University Hospital Olomouc
Brno University Hospital
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
  More Information

Additional Information:
Publications:
Responsible Party: Vaclav Prochazka, MD, PhD. MSc, MD,PhD,MSc, University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT01823211     History of Changes
Other Study ID Numbers: FNO-KVO-2, Plasek680-2
Study First Received: March 19, 2013
Last Updated: September 27, 2013
Health Authority: Czech Republic: Ethics Committee

Keywords provided by University Hospital Ostrava:
ICD (Implantable cardioverter-defibrillator)
Heart rate variability
MTWA (Microvolt T-alternans)
Magnetic resonance imaging (MRI)

Additional relevant MeSH terms:
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014