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AzTrials

Hypertrophic CardiomyopathyHCM-PETNCT03278457

Risk Stratification Using PET in HCM

An observational study of Hypertrophic Cardiomyopathy, run by Region Gävleborg at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertrophic Cardiomyopathy
What is being tested?
Positron Emission Tomography
How many people
25 participants
Where
1 siteSweden
Study dates
3 May 2017to 3 Jun 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients with hypertrophic cardiomyopathy (HCM) and an implantable defibrillator (ICD)

Who may be able to join

  • Hypertrophic cardiomyopathy, implantable cardioverter defibrillator, informed consent

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Peter Magnusson, MD contact

+46705089407

peter.magnusson@regiongavleborg.se

Jonny Nordström, MSc contact

+46725727670

jonny.nordstrom@regiongavleborg.se

Sweden1 site, 1 recruiting

  • Region Gavleborg

    Gävle, 80324

    Peter Magnusson, M.D., +46705089407, peter.magnusson@regiongavleborg.se

    Jonny Nordström, MSc, +46725727670, jonny.nordstrom@regiongavleborg.se

    Recruiting

Other trials in Sweden

About this study

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

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.

Read the 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.

Keywords
hypertrophic cardiomyopathy, implantable cardioverter defibrillator, positron emission tomography
Medical subject headings
Cardiomyopathy, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ventricular tachycardia (VT) vs myocardial blood flow

    Ventricular tachycardia vs positron emissions tomography parameter Myocardial blood flow (MBF)

    Measured: History of VT since receiving an implantable defibrillator within last 15 years

  2. Ventricular tachycardia (VT) vs ejection fraction

    Ventricular tachycardia vs positron emissions tomography parameter ejection fraction (EF)

    Measured: History of VT since receiving an implantable defibrillator within last 15 years

  3. Ventricular tachycardia (VT) vs mass

    Ventricular tachycardia vs positron emissions tomography parameter mass

    Measured: History of VT since receiving an implantable defibrillator within last 15 years

  4. Ventricular tachycardia (VT) vs wall thickness

    Ventricular tachycardia vs positron emissions tomography parameter wall thickness

    Measured: History of VT since receiving an implantable defibrillator within last 15 years

  5. Ventricular tachycardia (VT) vs oxygen consumption

    Ventricular tachycardia vs positron emissions tomography parameter oxygen consumption (MVO2)

    Measured: History of VT since receiving an implantable defibrillator within last 15 years

  6. Ventricular tachycardia (VT) vs sympathetic innervation

    Ventricular tachycardia vs positron emissions tomography parameter sympathetic innervation (retention index)

    Measured: History of VT since receiving an implantable defibrillator within last 15 years

  7. Ventricular tachycardia (VT) vs myocardial external efficiency

    Ventricular tachycardia vs positron emissions tomography parameter myocardial external efficiency (MEE)

    Measured: History of VT since receiving an implantable defibrillator within last 15 years

  8. Ventricular tachycardia (VT) vs stroke work

    Ventricular tachycardia vs positron emissions tomography parameter stroke work (SW)

    Measured: History of VT since receiving an implantable defibrillator within last 15 years

Secondary outcomes (9)

  1. Atrial fibrillation (AF) vs myocardial blood flow

    Atrial fibrillation vs positron emissions tomography parameter myocardial blood flow

    Measured: History of VT since receiving an implantable defibrillator within last 15 years

  2. Atrial fibrillation (AF) vs ejection fraction

    Atrial fibrillation vs positron emissions tomography parameter ejection fraction (EF)

    Measured: History of VT since receiving an implantable defibrillator within last 15 years

  3. Atrial fibrillation (AF) vs mass

    Atrial fibrillation vs positron emissions tomography parameter mass

    Measured: History of VT since receiving an implantable defibrillator within last 15 years

  4. Atrial fibrillation (AF) vs wall thickness

    Atrial fibrillation vs positron emissions tomography parameter wall thickness

    Measured: History of VT since receiving an implantable defibrillator within last 15 years

  5. Atrial fibrillation (AF) vs oxygen consumption

    Atrial fibrillation vs positron emissions tomography parameter oxygen consumption (MVO2)

    Measured: History of VT since receiving an implantable defibrillator within last 15 years

  6. Atrial fibrillation (AF) vs sympathetic innervation

    Atrial fibrillation vs positron emissions tomography parameter sympathetic innervation (retention index)

    Measured: History of VT since receiving an implantable defibrillator within last 15 years

  7. Atrial fibrillation (AF) vs myocardial external efficiency

    Atrial fibrillation vs positron emissions tomography parameter myocardial external efficiency (MEE)

    Measured: History of VT since receiving an implantable defibrillator within last 15 years

  8. Atrial fibrillation (AF) vs stroke work

    Atrial fibrillation vs positron emissions tomography parameter stroke work (SW)

    Measured: History of VT since receiving an implantable defibrillator within last 15 years

  9. Atrial size vs ventricular tachycardia

    atrial diameter, volume vs ventricular tachycardia

    Measured: History of VT since receiving an implantable defibrillator within last 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2017
  2. Study start3 May 2017
  3. Primary completion3 Jan 2018 (estimated)
  4. Study completion3 Jun 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03278457
Sponsor's protocol ID
2017021
Acronym
HCM-PET
Status last verified
Sep 2017
First submitted
21 Aug 2017
Last updated
11 Sep 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25173338

  • 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.

    PubMed 10952953

  • 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.

    PubMed 20069294

  • 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.

    PubMed 12651046

  • 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.

    PubMed 21377644

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertrophic Cardiomyopathy, run by Region Gävleborg at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Peter Magnusson, MD (+46705089407, peter.magnusson@regiongavleborg.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ventricular tachycardia (VT) vs myocardial blood flow (time frame: History of VT since receiving an implantable defibrillator within last 15 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03278457, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.

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