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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 27, 2014