Profitability Trial in Primary Preventive Implantable Cardioverter-defibrillator Recipients

Ischaemic Cardiomyopathy Clinical Trial

— HAPPIER  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01823211
• Other study ID #: FNO-KVO-2
• Secondary ID: Plasek680-2
• Status: Terminated
• Phase: N/A
• First received: March 19, 2013
• Last updated: October 27, 2016
• Start date: March 2013
• Est. completion date: April 2016

Study information

• Verified date: October 2016
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiomyopathies
• Ischaemic Cardiomyopathy
• Non-ischaemic Cardiomyopathy

Locations

Country	Name	City	State
Czech Republic	Brno University Hospital	Brno
Czech Republic	University Hospital Olomouc	Olomouc
Czech Republic	University Hospital Ostrava	Ostrava

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Ostrava	Brno University Hospital, University Hospital Olomouc

Country where clinical trial is conducted

Czech Republic, 

References & Publications (2)

Seely AJ, Macklem PT. Complex systems and the technology of variability analysis. Crit Care. 2004 Dec;8(6):R367-84. Epub 2004 Sep 22. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	all-cause mortality	mortality from both cardiovascular and non-cardiovascular cause	36-months	No
Other	Cardiovascular mortality	death from strictly cardiovascular cause	36-months	No
Primary	ventricular tachyarrhytmia	ventricular tachycardia equal or > 250/min,ventricular fibrillation, arrhythmic storm	36 months	No
Secondary	sudden cardiac death	death in 24-hours after symptom onset	36-months	No