Condition category
Circulatory System
Date applied
07/09/2018
Date assigned
04/10/2018
Last edited
04/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Arrhythmogenic cardiomyopathy (AC) is an inherited disease that can cause sudden cardiac death (SCD). Cardiac involvement is characterised by heart muscle cell loss. This leads to an enlarged heart, predominantly in the right ventricle (RV), which can then progress to heart failure. Patchy cell loss in the heart wall can cause electrical instability, which manifests as ventricular arrhythmia, which increases the risk of sudden death. The treatment is based on anti-arrhythmic medication and insertion of an implantable cardioverter defibrillator (ICD) , which protects from SCD in case of ventricular arrhythmia. The treatment for heart failure depends on the progress of the disease. In some cases a heart transplant is needed.
Cardiac MRI, the gold standard for RV analysis is not suitable for patients with ICD and echocardiography is often inadequate for this task. Regardless, disease progression still needs to be analysed.
Recent developments in CT imaging and image analysis have changed the options. CT scanning of the heart can now be performed with very low irradiation to the patient (less than 3 mSv). Our research team has developed a new model to measure heart volume and wall deformation using cardiac CT. The aim of this study is to assess ventricular volume and heart function using cardiac CT in AC patients with ICD to follow-up the progress of the disease.

Who can participate?
Adult patients from the tertiary care centre in Linköping University Hospital, Sweden, with a definite diagnosis of AC and implanted ICD.

What does the study involve?
Participants will undergo an examination of their heart using a CT scan, along with additional standard clinical follow-up echocardiography. For patients older than 60, blood samples will be taken to check kidney function.

What are the possible benefits and risks of participating?
The benefits are an increased ability to detect disease progression more accurately, in order to optimise the treatment to prevent the development of heart failure.
During the CT scan examination, the patient receives intravenous contrast. This could harm kidney function, particularly if an individual already has marginal kidney disease. A blood test is done prior to CT scan to safeguard. Any time a venipuncture is performed, there is a risk of a haematoma.

Where is the study run from?
University Hospital of Linköping (Sweden)

When is the study starting and how long is it expected to run for?
December 2017 to December 2019]

Who is funding the study?
Hjärt-Lungfonden (Sweden)

Who is the main contact?
Meriam Åström Aneq
Meriam.astrom.aneq@regionostergotland.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Meriam Åström Aneq

ORCID ID

Contact details

Dpt of Clinical physiology
Linköping
58185
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ARVC och plötslig hjärtdöd

Study information

Scientific title

Evaluation of ventricular function in patients with arrhythmogenic cardiomyopathy using multimodality imaging

Acronym

Study hypothesis

Arrhythmogenic cardiomyopathy (AC) is an hereditary heart disease characterised by myocardial cell loss and fibrosis resulting in electrophysiological abnormalities and potentially fatal arrhythmias, as well as contractile dysfunction of the right (RV) and left ventricles (LV). The treatment of AC is based on antiarrythmic therapy and the insertion of an implantable cardioverter defibrillator (ICD), which means that the assessment of the heart by cardiac magnetic resonance (CMR) not suitable. We use a new software on cardiac CT to track and quantify global and segmental changes in the ventricular function in AC patients with an ICD. We hypothesise that this new software on cardiac CT could help following the progress of disease to adjust the treatment.

Ethics approval

Regional Ethical board in Linköping (EPN), 21/03/2018, 2018/35-31

Study design

Observational prospective single-centre case series

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Arrhythmogenic cardiomyopathy

Intervention

Patients fulfilling definite Task Force Criteria for AC carrying an ICD undergo cardiac CT for heart function analysis. The study examination includes CT-scanning of the heart. A radiology technician performs the CT scan. During the test, the patient is lying on a table that is moved through the opening of the CT scanner. The examination takes 8-10 minutes. For patients older than 60 years old, renal function is checked via a blood sample to safeguard the use of iodine contrast.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Assessment of the right and left ventricular volume and function, assessed using time-resolved CT scanning of the heart at the time of the scan

Secondary outcome measures

Software ability to detect regional, focal ventricular abnormalities in AC patients with ICD, assessed using a software that detects myocardial “pixels” and calculates the changes during the heart cycle at the time of the scan

Overall trial start date

16/12/2017

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Referred for diagnostic cardiac CT
2. Fulfil definite Task Force Criteria for arrhythmogenic cardiomyopathy
3. Implantable cardioverter defibrillator
4. Aged 18 years or older

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

All patients at Linköping hospital with definite AC diagnosis and an ICD are included.

Participant exclusion criteria

1. Renal insufficiency
2. Pregnant women

Recruitment start date

02/05/2018

Recruitment end date

30/11/2018

Locations

Countries of recruitment

Sweden

Trial participating centre

University hospital of Linköping
Universitetssjukhuset
Linköping
58185
Sweden

Sponsor information

Organisation

Institute of medicine and health care. Dpt of clinical physiology

Sponsor details

University hospital of Linköping
Linköping
58185
Sweden

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

Hjärt- lungfonden

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from Dr M. Åström Aneq. meriam.astrom.aneq@regionostergotland.se. Measurements of heart volume and wall strain will be available by the end of the recruitment of patients and analysis of data, planned on 31/05/2019. Patients sign a consent that the CT measurements will be used for publication. All measurements are anonymised.

Intention to publish date

31/12/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes