Risk Stratification Using PET in HCM

Hypertrophic Cardiomyopathy Clinical Trial

— HCM-PET  

Official title:

Risk Stratification Using Positron Emission Tomography (PET) in Hypertrophic Cardiomyopathy (HCM)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03278457
• Other study ID #: 2017021
• Status: Recruiting
• Phase: N/A
• First received: August 21, 2017
• Last updated: September 7, 2017
• Start date: May 3, 2017
• Est. completion date: June 3, 2018

Study information

• Verified date: September 2017
• Source: Region Gävleborg
• Contact: Peter Magnusson, MD
• Phone: +46705089407
• Email: peter.magnusson[@]regiongavleborg.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 3, 2018
• Est. primary completion date: January 3, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

Diagnostic Test:
• Positron Emission Tomography
Positron Emission Tomography

Locations

Country	Name	City	State
Sweden	Region Gavleborg	Gävle

Sponsors (4)

Lead Sponsor	Collaborator
Region Gävleborg	Dalarna County Council, Sweden, Landstinget i Värmland, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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. — View 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. — View 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. — View Citation

Timmer SA, Germans T, Götte MJ, Rüssel 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. — View Citation

Timmer SA, Germans T, Götte MJ, Rüssel 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventricular tachycardia (VT) vs myocardial blood flow	Ventricular tachycardia vs positron emissions tomography parameter Myocardial blood flow (MBF)	History of VT since receiving an implantable defibrillator within last 15 years
Primary	Ventricular tachycardia (VT) vs ejection fraction	Ventricular tachycardia vs positron emissions tomography parameter ejection fraction (EF)	History of VT since receiving an implantable defibrillator within last 15 years
Primary	Ventricular tachycardia (VT) vs mass	Ventricular tachycardia vs positron emissions tomography parameter mass	History of VT since receiving an implantable defibrillator within last 15 years
Primary	Ventricular tachycardia (VT) vs wall thickness	Ventricular tachycardia vs positron emissions tomography parameter wall thickness	History of VT since receiving an implantable defibrillator within last 15 years
Primary	Ventricular tachycardia (VT) vs oxygen consumption	Ventricular tachycardia vs positron emissions tomography parameter oxygen consumption (MVO2)	History of VT since receiving an implantable defibrillator within last 15 years
Primary	Ventricular tachycardia (VT) vs sympathetic innervation	Ventricular tachycardia vs positron emissions tomography parameter sympathetic innervation (retention index)	History of VT since receiving an implantable defibrillator within last 15 years
Primary	Ventricular tachycardia (VT) vs myocardial external efficiency	Ventricular tachycardia vs positron emissions tomography parameter myocardial external efficiency (MEE)	History of VT since receiving an implantable defibrillator within last 15 years
Primary	Ventricular tachycardia (VT) vs stroke work	Ventricular tachycardia vs positron emissions tomography parameter stroke work (SW)	History of VT since receiving an implantable defibrillator within last 15 years
Secondary	Atrial fibrillation (AF) vs myocardial blood flow	Atrial fibrillation vs positron emissions tomography parameter myocardial blood flow	History of VT since receiving an implantable defibrillator within last 15 years
Secondary	Atrial fibrillation (AF) vs ejection fraction	Atrial fibrillation vs positron emissions tomography parameter ejection fraction (EF)	History of VT since receiving an implantable defibrillator within last 15 years
Secondary	Atrial fibrillation (AF) vs mass	Atrial fibrillation vs positron emissions tomography parameter mass	History of VT since receiving an implantable defibrillator within last 15 years
Secondary	Atrial fibrillation (AF) vs wall thickness	Atrial fibrillation vs positron emissions tomography parameter wall thickness	History of VT since receiving an implantable defibrillator within last 15 years
Secondary	Atrial fibrillation (AF) vs oxygen consumption	Atrial fibrillation vs positron emissions tomography parameter oxygen consumption (MVO2)	History of VT since receiving an implantable defibrillator within last 15 years
Secondary	Atrial fibrillation (AF) vs sympathetic innervation	Atrial fibrillation vs positron emissions tomography parameter sympathetic innervation (retention index)	History of VT since receiving an implantable defibrillator within last 15 years
Secondary	Atrial fibrillation (AF) vs myocardial external efficiency	Atrial fibrillation vs positron emissions tomography parameter myocardial external efficiency (MEE)	History of VT since receiving an implantable defibrillator within last 15 years
Secondary	Atrial fibrillation (AF) vs stroke work	Atrial fibrillation vs positron emissions tomography parameter stroke work (SW)	History of VT since receiving an implantable defibrillator within last 15 years
Secondary	Atrial size vs ventricular tachycardia	atrial diameter, volume vs ventricular tachycardia	History of VT since receiving an implantable defibrillator within last 15 years