Assessment of subclinical right ventricular dysfunction in Systemic Sclerosis (SSc) using blood oxygen level dependent (BOLD) myocardial resonance imaging and strain echocardiography

Not Applicable

• Conditions: Systemic sclerosis; Cardiovascular - right ventricular dysfunction; Skin; Inflammatory and Immune System - Autoimmune diseases; Cardiovascular - Other cardiovascular diseases; Skin - Other skin conditions

• Registration Number: ACTRN12621000936820
• Lead Sponsor: Flinders Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-16
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 88

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

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

• Study Type: Interventional
• Study Design: Not specified