Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000936820
Ethics application status
Approved
Date submitted
15/03/2021
Date registered
16/07/2021
Date last updated
16/07/2021
Date data sharing statement initially provided
16/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of subclinical right ventricular dysfunction in Systemic Sclerosis (SSc) using blood oxygen level dependent (BOLD) myocardial resonance imaging and strain echocardiography
Scientific title
Assessment of subclinical right ventricular dysfunction in Systemic Sclerosis (SSc) using blood oxygen level dependent (BOLD) myocardial resonance imaging and strain echocardiography
Secondary ID [1] 303662 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BOLD-SSc
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic sclerosis 321048 0
Cardiovascular - right ventricular dysfunction 321049 0
Skin 321537 0
Condition category
Condition code
Inflammatory and Immune System 318850 318850 0 0
Autoimmune diseases
Cardiovascular 318851 318851 0 0
Other cardiovascular diseases
Skin 319286 319286 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will undergo BOLD and Parametric T1/T2 mapping Cardiac Magnetic Resonance (CMR) of their RV and Speckle tracking Echocardiography (Echo).

Both patient population and normal volunteers will have CMR and echo assessments. Echo assessment will apart of the patient populations annual routine follow up with their rheumatologist. CMR assessment will be done within 3 months of this echo.

CMR will be carried out in the presence of radiographer and cardiologist. Echo will be performed by sonographer.

During CMR scan, participants will be administered with adenosine and gadolinium. Adenosine is a drug that mimics the effect of exercise on your heart. Cardiac images will be taken both at rest and at adenosine stress. There will be no designated time between rest and stress periods however if the patient's conditions requires this, adequate time will be given.
Intervention code [1] 319962 0
Early detection / Screening
Comparator / control treatment
Normal healthy controls will be recruited and have the same assessments
Control group
Active

Outcomes
Primary outcome [1] 326803 0
Right ventricular myocardial oxygenation during rest and stress (OS-CMR delta SI) in SSc patients
Timepoint [1] 326803 0
The primary end-point of OS-CMR is one variable. The OS-CMR will be assessed in the CMR, at single session.
Secondary outcome [1] 392716 0
Diffuse interstitial RV myocardial fibrosis in SSc patients
Timepoint [1] 392716 0
At single assessment session
Secondary outcome [2] 392717 0
RV strain in SSc and healthy participants using echocardiography speckle tracking
Timepoint [2] 392717 0
At single assessment session

Eligibility
Key inclusion criteria
Patient population:
-Male and female aged greater than/ equal to 18 years
-Confirmed diagnosis of systemic sclerosis
-Screen negative for PAH based on Australian Scleroderma Interest Group (ASIG) algorithm or normal mean PAP (8-20 mmHg; assessed by right heart catheterisation). (Screen negative implies NT-proBNP < 210 pg/ml and pulmonary function test demonstrating DLCO > 70% predicted with FVC/DLCO <1.8)
-Normal echocardiography.
-No history of cardiac disease (myocardial infarction, angina, cardiomyopathy/heart failure, pulmonary thromboembolism and significant valvular heart disease).

Normal healthy controls:
-Male and female aged greater than/ equal to 18 years
-No history of cardiac disease
-Normal screening echocardiogram (post consent) which includes assessment of left and right ventricular function, diastolic function and pulmonary artery pressures
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Inability to provide informed consent
-Prior documented LV/RV systolic dysfunction.
-Presence of significant coronary artery disease (>50% stenosis).
-Contraindications of CMR, including:
o Extreme claustrophobia
o Implantable cardiac devices and other contra-indications to CMR (metal in eyes, intracranial clips)
o Inability to lie flat for one hour
-Contraindication to gadolinium, including:
o Estimated Glomerular Filtration Rate (eGFR) of <45mL/min/1.73m2
-Contraindications to adenosine, including:
o second or third degree atrioventricular block
o obstructive pulmonary disease
o dipyridamole use

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a prospective case-control study with a study population of male and female, consists of 71 SSc patients and 17 normal volunteers (NV) matched for age and gender will be recruited.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/07/2021
Actual
Date of last participant enrolment
Anticipated
31/05/2022
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
88
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 18882 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 18883 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 33390 0
5000 - Adelaide
Recruitment postcode(s) [2] 33389 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 308075 0
Other
Name [1] 308075 0
SAHMRI
Country [1] 308075 0
Australia
Primary sponsor type
Other
Name
Flinders Medical Centre
Address
1, Flinders Drive
Bedford Park
SA 5042
Country
Australia
Secondary sponsor category [1] 308818 0
None
Name [1] 308818 0
Address [1] 308818 0
Country [1] 308818 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308064 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 308064 0
1, Flinders Drive
Bedford Park
SA 5042
Ethics committee country [1] 308064 0
Australia
Date submitted for ethics approval [1] 308064 0
23/11/2020
Approval date [1] 308064 0
17/03/2021
Ethics approval number [1] 308064 0

Summary
Brief summary
Systemic Sclerosis (SSc) is an autoimmune disorder in which normal tissue is replaced with scar tissue. Normally, the immune system helps to defend the body against various infections and diseases. In SSc, the immune system stimulates the cells to produce excess collagen (protein). The excess collagen is deposited in skin and other organs (heart muscle, lungs, blood vessels, skeletal muscles and joints) causing hardening and thickening of normal tissues (similar to scar formation). The prevalence of SSc is 443 per million population, and women are more commonly affected. One of the major causes of SSc-related death is right heart (right ventricle, RV) failure, and thus assessment of its function is important in determining survival. The RV is affected through primary heart muscle involvement and/or due to involvement of blood vessels supplying the heart. RV dysfunction is silent until advanced and routine investigations do not detect it at an early stage. Hence, there is a need for a safe and sensitive non-invasive technique for early detection of RV dysfunction. Advanced imaging techniques like cardiac magnetic resonance imaging show potential in detecting early abnormalities in the RV, before symptoms present. We propose to utilize this technique to detect early RV abnormalities in patients with SSc. This will identify those at an increased risk and allow initiation of disease modifying therapy, thereby improving outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109398 0
Prof Joseph Selvanayagam
Address 109398 0
Flinders Medical Centre - Cardiology
1, Fliinders Drive
Bedford Park
SA 5042
Country 109398 0
Australia
Phone 109398 0
+61 8 8204 5619
Fax 109398 0
+ 61 8 8204 5625
Email 109398 0
joseph.selva@sa.gov.au
Contact person for public queries
Name 109399 0
Prof Joseph Selvanayagam
Address 109399 0
Flinders Medical Centre - Cardiology
1, Fliinders Drive
Bedford Park
SA 5042
Country 109399 0
Australia
Phone 109399 0
+61 8 8204 5619
Fax 109399 0
+ 61 8 8204 5625
Email 109399 0
joseph.selva@sa.gov.au
Contact person for scientific queries
Name 109400 0
Prof Joseph Selvanayagam
Address 109400 0
Flinders Medical Centre - Cardiology
1, Fliinders Drive
Bedford Park
SA 5042
Country 109400 0
Australia
Phone 109400 0
+61 8 8204 5619
Fax 109400 0
+ 61 8 8204 5625
Email 109400 0
joseph.selva@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.