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The Scleroderma-Pulmonary Arterial Hypertension Invention with Apixaban (SPHInX) Study

Chief investigator

Dr Mandana Nikpoud, St Vincent's Hospital, Melbourne


The study

The SPHInX Study is testing a new treatment for Scleroderma-related Pulmonary Arterial Hypertension. The purpose of the SPHInX Study is to determine whether there are any health benefits to be gained from the addition of a blood-thinning medication, Apixaban, for patients with Scleroderma-related Pulmonary Arterial Hypertension in addition to their already prescribed therapy. 


Who can participate in the study?

You may be eligible to participate if;


- you are between 18-75 years old

- have been diagnosed with Scleroderma-related Pulmonary Arterial Hypertension
- currently take at least one of the following medications: Macitentan, Bosentan, Ambrisentan, Sildenafil or Tadalafil
- can walk further than 50 metres in 6 minutes


What's involved


The following study procedures will be performed during most visits:

- physical examination
- complete questionnaire about your condition and how it affects your life
- 6 minute walk test with corresponding breathlessness index
- electrocardiogram (ECG) recording the electrical activity in your heart
- two blood samples will be collected at the 1, 6 and 24 month visits

You will also receive regular telephone calls from the study team, to confirm your current medications and to ask questions about any changes to your health. You will also be asked to complete a health diary. Most visits are timed to occur at the same time as your normal, 6 monthly, clinic visits, limiting the number of additional visits you need to attend to participate in the study.


How long will participants be actively involved in the study?

3 years 

Closing date

 
31 December, 2017 

Ethics and funding

This study has been approved by St Vincent's Hospital, Melbourne (project number HREC/14/SVHM/15). This research is funded by a National Health and Medical Research Council (NHMRC) Project Grant.

Contact information 

To express your interest in participating in this study please contact:
Ms Kate Scott 
Clinical Trial Coordinator, St Vincent's Hospital, Melbourne
Telephone: 03 9231 3981
Email: kate.scott@svha.org.au

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