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Trial record 20 of 38 for:    alternans

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01823211
Recruitment Status : Terminated (Problems with ensuring patient examinations defined in the protocol of the study)
First Posted : April 4, 2013
Last Update Posted : October 28, 2016
University Hospital Olomouc
Brno University Hospital
Information provided by (Responsible Party):
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.

Condition or disease
Ischaemic Cardiomyopathy Non-ischaemic Cardiomyopathy

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 50 participants
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
Study Start Date : March 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. ventricular tachyarrhytmia [ Time Frame: 36 months ]
    ventricular tachycardia equal or > 250/min,ventricular fibrillation, arrhythmic storm

Secondary Outcome Measures :
  1. sudden cardiac death [ Time Frame: 36-months ]
    death in 24-hours after symptom onset

Other Outcome Measures:
  1. all-cause mortality [ Time Frame: 36-months ]
    mortality from both cardiovascular and non-cardiovascular cause

  2. Cardiovascular mortality [ Time Frame: 36-months ]
    death from strictly cardiovascular cause

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heart-failure clinic,primary care clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01823211

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Czech Republic
Brno University Hospital
Brno, Czech Republic, 62500
University Hospital Olomouc
Olomouc, Czech Republic, 775 20
University Hospital Ostrava
Ostrava, Czech Republic, 70852
Sponsors and Collaborators
University Hospital Ostrava
University Hospital Olomouc
Brno University Hospital
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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

Additional Information:

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Responsible Party: University Hospital Ostrava Identifier: NCT01823211     History of Changes
Other Study ID Numbers: FNO-KVO-2
Plasek680-2 ( Registry Identifier: )
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
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:
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Heart Diseases
Cardiovascular Diseases