Clinical trial NCT01823211: Profitability Trial in Primary Preventive Implantable Cardioverter-defibrillator Recipients
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ischaemic Cardiomyopathy
Non-ischaemic Cardiomyopathy
Keywords: ICD (Implantable cardioverter-defibrillator)
Heart rate variability
MTWA (Microvolt T-alternans)
Magnetic resonance imaging (MRI)
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
Collaborators: name: University Hospital Olomouc
name: Brno University Hospital
First posted: 2013-04-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart-failure clinic,primary care clinic

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.

Eligibility 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

Primary outcomes:
measure: ventricular tachyarrhytmia
timeFrame: 36 months
Secondary outcomes:
measure: sudden cardiac death
timeFrame: 36-months
Other outcomes:
measure: all-cause mortality
timeFrame: 36-months
measure: Cardiovascular mortality
timeFrame: 36-months
Locations:
city: Brno
country: Czech Republic
facility: Brno University Hospital
city: Olomouc
country: Czech Republic
facility: University Hospital Olomouc
city: Ostrava
country: Czech Republic
facility: University Hospital Ostrava
Study officials:
affiliation: Department of Cardiology,University hospital Ostrava
name: Jiri Plasek, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department of Cardiology,University Hospital Olomouc
name: Milos Taborsky, MD, PhD, FESC
role: STUDY_CHAIR
affiliation: Department of Cardiology,University Hospital Brno-Bohunice
name: Lubos Krivan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology,University Hospital Olomouc
name: Ondrej Moravec, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seely AJ, Macklem PT. Complex systems and the technology of variability analysis. Crit Care. 2004 Dec;8(6):R367-84. doi: 10.1186/cc2948. Epub 2004 Sep 22.
citation: Zipes DP, Camm AJ, Borggrefe M, Buxton AE, Chaitman B, Fromer M, Gregoratos G, Klein G, Moss AJ, Myerburg RJ, Priori SG, Quinones MA, Roden DM, Silka MJ, Tracy C, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL, Smith SC Jr, Jacobs AK, Adams CD, Antman EM, Anderson JL, Hunt SA, Halperin JL, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death) developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Europace. 2006 Sep;8(9):746-837. doi: 10.1093/europace/eul108. Epub 2006 Aug 25. No abstract available.