Clinical trial NCT03278457: Risk Stratification Using PET in HCM
Official title: Risk Stratification Using Positron Emission Tomography (PET) in Hypertrophic Cardiomyopathy (HCM)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertrophic Cardiomyopathy
Keywords: hypertrophic cardiomyopathy
implantable cardioverter defibrillator
positron emission tomography
Lead sponsor: Region Gävleborg
Sponsor class: OTHER
Collaborators: name: Landstinget i Värmland
name: Dalarna County Council, Sweden
name: Uppsala University Hospital
First posted: 2017-09-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hypertrophic cardiomyopathy (HCM) and an implantable defibrillator (ICD)

Brief summary: The overall rationale is to reduce the risk of sudden cardiac death in individuals with hypertrophic cardiomyopathy (HCM). The novel approach of this study is to correlate Positron Emission Tomography (PET) findings to ventricular arrhythmias detected by the implantable cardioverter defibrillator (ICD). This could potentially lead to an improved risk stratification of HCM patients.

Detailed description: Positron Emission Tomography (PET) is a functional imaging technique that utilizes radioactive tracers to gain information on physiological or pathophysiological processes in vivo. Different tracers can provide information on different processes of interest. In cardiology, metabolic processes consuming oxygen (aerobic) can be studied with 11-Carbon-Acetate, sympathetic innervation can be studied with 11-Carbon-hydroxyephedrine and using 15-Oxygen-water the myocardial blood flow. Structural information of the heart such as left ventricular mass, left ventricular volumes and wall thickness can also be calculated with PET.

The aim is to correlate PET parameters and burden of ventricular arrhythmias in order to improve risk stratification in HCM.

Eligibility criteria: Inclusion Criteria:

* Hypertrophic cardiomyopathy, implantable cardioverter defibrillator, informed consent

Exclusion Criteria:

* Patients younger than 18 years, pregnancy, breast feeding, claustrophobia, intolerance/allergic reaction to adenosin or mannitol, severe hypotension, unstable angina pectoris, incompensated systolic heart failure, increased intracranial pressure, hypovolemia, dipyramidole.

Primary outcomes:
measure: Ventricular tachycardia (VT) vs myocardial blood flow
timeFrame: History of VT since receiving an implantable defibrillator within last 15 years
measure: Ventricular tachycardia (VT) vs ejection fraction
timeFrame: History of VT since receiving an implantable defibrillator within last 15 years
measure: Ventricular tachycardia (VT) vs mass
timeFrame: History of VT since receiving an implantable defibrillator within last 15 years
measure: Ventricular tachycardia (VT) vs wall thickness
timeFrame: History of VT since receiving an implantable defibrillator within last 15 years
measure: Ventricular tachycardia (VT) vs oxygen consumption
timeFrame: History of VT since receiving an implantable defibrillator within last 15 years
measure: Ventricular tachycardia (VT) vs sympathetic innervation
timeFrame: History of VT since receiving an implantable defibrillator within last 15 years
measure: Ventricular tachycardia (VT) vs myocardial external efficiency
timeFrame: History of VT since receiving an implantable defibrillator within last 15 years
measure: Ventricular tachycardia (VT) vs stroke work
timeFrame: History of VT since receiving an implantable defibrillator within last 15 years
Secondary outcomes:
measure: Atrial fibrillation (AF) vs myocardial blood flow
timeFrame: History of VT since receiving an implantable defibrillator within last 15 years
measure: Atrial fibrillation (AF) vs ejection fraction
timeFrame: History of VT since receiving an implantable defibrillator within last 15 years
measure: Atrial fibrillation (AF) vs mass
timeFrame: History of VT since receiving an implantable defibrillator within last 15 years
measure: Atrial fibrillation (AF) vs wall thickness
timeFrame: History of VT since receiving an implantable defibrillator within last 15 years
measure: Atrial fibrillation (AF) vs oxygen consumption
timeFrame: History of VT since receiving an implantable defibrillator within last 15 years
measure: Atrial fibrillation (AF) vs sympathetic innervation
timeFrame: History of VT since receiving an implantable defibrillator within last 15 years
measure: Atrial fibrillation (AF) vs myocardial external efficiency
timeFrame: History of VT since receiving an implantable defibrillator within last 15 years
measure: Atrial fibrillation (AF) vs stroke work
timeFrame: History of VT since receiving an implantable defibrillator within last 15 years
measure: Atrial size vs ventricular tachycardia
timeFrame: History of VT since receiving an implantable defibrillator within last 15 years
Other outcomes:
Locations:
city: Gävle
country: Sweden
facility: Region Gavleborg
Study officials:
affiliation: Region Gävleborg
name: Jens Sörensen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: Timmer SA, Germans T, Gotte MJ, Russel IK, Dijkmans PA, Lubberink M, ten Berg JM, ten Cate FJ, Lammertsma AA, Knaapen P, van Rossum AC. Determinants of myocardial energetics and efficiency in symptomatic hypertrophic cardiomyopathy. Eur J Nucl Med Mol Imaging. 2010 Apr;37(4):779-88. doi: 10.1007/s00259-009-1350-3. Epub 2010 Jan 13.
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: Timmer SA, Germans T, Gotte MJ, Russel IK, Lubberink M, Ten Berg JM, Ten Cate FJ, Lammertsma AA, Knaapen P, van Rossum AC. Relation of coronary microvascular dysfunction in hypertrophic cardiomyopathy to contractile dysfunction independent from myocardial injury. Am J Cardiol. 2011 May 15;107(10):1522-8. doi: 10.1016/j.amjcard.2011.01.029. Epub 2011 Mar 4.