Clinical trial NCT03259113: Insertable Cardiac Monitors in Hypertrophic Cardiomyopathy
Official title: EvaLuation Using Cardiac Insertable Devices And TelephonE in Hypertrophic CardioMyopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertrophic Cardiomyopathy
Keywords: insertable cardiac monitor
atrial fibrillation
non-sustained ventricular tachycardia
Lead sponsor: Region Gävleborg
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
name: Norrlands University Hospital
First posted: 2017-08-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Consecutive insertable cardiac monitors in 30 patients with hypertrophic cardiomyopathy
Primary purpose: DIAGNOSTIC

Brief summary: Hypertrophic cardiomyopathy (HCM) is associated with sudden cardiac death and an increased risk of atrial fibrillation and subsequent embolic event. An insertable cardiac monitor will provide data on cardiac rhythm over a period of 18 months. This will provide an extended monitoring far longer than 24-48 hours of Holter monitoring as is currently usual care. Therefore, detection of arrhythmias could be used in risk stratification and decision-making with regard to offer an implantable defibrillator and anticoagulants.

Detailed description: Detection of non-sustained ventricular tachycardia (NSVT) and atrial fibrillation (AF) using an insertable cardiac device monitor (SJM Confirm XT) which is connected to the patients smart phone and monitored for 18 months.

Eligibility criteria: Inclusion Criteria:

* hypertrophic cardiomyopathy

Exclusion Criteria:

* aortic stenosis (moderate, severe)
* hypertrophic cardiomyopathy associated with metabolic disease (e.g. Fabry) and syndromes (e.g. Noonan)
* systolic heart failure
* cardiac device (previous pacemaker, implantable defibrillator )
* history of myocardial infarction
* percutaneous coronary intervention and/or coronary artery by-pass grafting
* pulmonary vein isolation, Maze surgery, ventricular tachycardia ablation, ectopic atrial tachycardia ablation
* renal clearance below 40
* malignancy or other comorbidity with less than five years life expectancy
* pregnancy of planned within 18 months
* drug addiction, severe mental disease
* not able to participate in 18 months follow-up
* 5 years risk more than 6% according HCM risk calculator of European Society of Cardiology guidelines.

Primary outcomes:
measure: NSVT
timeFrame: 18 months
Secondary outcomes:
measure: AF
timeFrame: 18 months
Other outcomes:
Locations:
city: Gävle
country: Sweden
facility: Region Gavleborg
Study officials:
affiliation: Norrlands Universitetssjukhus
name: Stellan Mörner, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Region Gävleborg
name: Peter Magnusson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elliott PM, Gimeno JR, Thaman R, Shah J, Ward D, Dickie S, Tome Esteban MT, McKenna WJ. Historical trends in reported survival rates in patients with hypertrophic cardiomyopathy. Heart. 2006 Jun;92(6):785-91. doi: 10.1136/hrt.2005.068577. Epub 2005 Oct 10.
citation: Maron BJ, Casey SA, Hauser RG, Aeppli DM. Clinical course of hypertrophic cardiomyopathy with survival to advanced age. J Am Coll Cardiol. 2003 Sep 3;42(5):882-8. doi: 10.1016/s0735-1097(03)00855-6.
citation: Maron BJ, Olivotto I, Spirito P, Casey SA, Bellone P, Gohman TE, Graham KJ, Burton DA, Cecchi F. Epidemiology of hypertrophic cardiomyopathy-related death: revisited in a large non-referral-based patient population. Circulation. 2000 Aug 22;102(8):858-64. doi: 10.1161/01.cir.102.8.858.
citation: Kofflard MJ, Ten Cate FJ, van der Lee C, van Domburg RT. Hypertrophic cardiomyopathy in a large community-based population: clinical outcome and identification of risk factors for sudden cardiac death and clinical deterioration. J Am Coll Cardiol. 2003 Mar 19;41(6):987-93. doi: 10.1016/s0735-1097(02)03004-8.
citation: Elliott PM, Sharma S, Varnava A, Poloniecki J, Rowland E, McKenna WJ. Survival after cardiac arrest or sustained ventricular tachycardia in patients with hypertrophic cardiomyopathy. J Am Coll Cardiol. 1999 May;33(6):1596-601. doi: 10.1016/s0735-1097(99)00056-x.
citation: American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Failure Society of America; Heart Rhythm Society; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; Gersh BJ, Maron BJ, Bonow RO, Dearani JA, Fifer MA, Link MS, Naidu SS, Nishimura RA, Ommen SR, Rakowski H, Seidman CE, Towbin JA, Udelson JE, Yancy CW. 2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Thorac Cardiovasc Surg. 2011 Dec;142(6):1303-38. doi: 10.1016/j.jtcvs.2011.10.019. No abstract available.
citation: Authors/Task Force members; Elliott PM, Anastasakis A, Borger MA, Borggrefe M, Cecchi F, Charron P, Hagege AA, Lafont A, Limongelli G, Mahrholdt H, McKenna WJ, Mogensen J, Nihoyannopoulos P, Nistri S, Pieper PG, Pieske B, Rapezzi C, Rutten FH, Tillmanns C, Watkins H. 2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy: the Task Force for the Diagnosis and Management of Hypertrophic Cardiomyopathy of the European Society of Cardiology (ESC). Eur Heart J. 2014 Oct 14;35(39):2733-79. doi: 10.1093/eurheartj/ehu284. Epub 2014 Aug 29. No abstract available.
citation: Magnusson P, Morner S. EvaLuation Using Cardiac Insertable Devices And TelephonE in Hypertrophic Cardiomyopathy (ELUCIDATE HCM): A prospective observational study on incidence of arrhythmias. J Cardiovasc Electrophysiol. 2021 Jan;32(1):129-135. doi: 10.1111/jce.14792. Epub 2020 Nov 4.