FAST Therapy Trial Update

September 20, 2016

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We are very pleased to update you of our progress during this exciting time. Our new updated and improved study protocol has been approved by Health Canada and new sites will therefore be trained and activated on this new protocol!

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Those who were about to be activated on the old protocol should make an amendment in order to move right away to the new protocol and new database (RCT & Registry).

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As the study activation process takes time and resources from both Sponsor and the participating site, it is most efficient to get approval for the new protocol before study activation.

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Please see the new information sections for easy to review summaries of:

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• Study Overview

• Study Set-up

• Site Activation Procedures

• Eligibility

• Outcomes

• RCT Therapy Arms

 

There is also a section called Frequently Asked Questions which aims to quickly give you feedback to questions commonly asked and may help you with your planning.

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PROTOCOL

The protocol is largely the same except for a few important changes below. We have also clarified text around procedures and improved our recommendations for adverse event documentation and reporting and incorporated them into the protocol.

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Most significant protocol changes:

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1. The ability of sites to confirm eligibility in REDCap and randomize patients without waiting for echo core lab review (review is still performed and can be requested urgently but is not a requirement anymore prior to enrolment).

2. The outcome of Term delivery with a normal cardiac rhythm is now ≥37 0/7 weeks (instead of ≥38 0/7 as it was previously). See Outcomes section for more information.

3. Enrolment cut-off is now ˂36 weeks gestation (because of the term definition change). See Eligibility section for more information.

 

Participation in RCT & Registry

Although we have tried our very best to be as inclusive as possible, the number of sites invited to participate in the RCT portion of the trial has been reduced to 30 sites. We anticipate we can reach our target enrollment with these 30 sites if we wisely select sites and provide them with enough resources.

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We have been working hard to acquire additional funds but have not yet been able to secure enough funding to allow us to include as many centres as originally hoped. In addition it has come to our attention that additional funds are required for per patient reimbursements as the amount of administrative work required to satisfy Health Canada regulatory requirements is far more than expected from the start. We are therefore restricting the number of sites and increasing reimbursements.

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The following countries have been selected based on feasibility to participate in the RCT for this phase I.

1. Canada (select sites)

2. UK

3. Netherlands

4. USA (select sites)

5. Germany

 

Additional sites and countries would only be included in the RCT for phase II if additional funding is obtained by the Sponsor or by National Coordinating Centres.

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All other sites/countries are invited to participate in the Registry which will soon be ready for activation. The regulatory requirements for the Registry is far less and the set-up will be much faster. We are therefore focusing our reimbursements on the RCT portion which includes a large amount of administrative work before and during the trial to meet regulatory requirements.

 

RCT SET UP

Countries/sites in this Phase I list will receive a more detailed update for how the transition to the new protocol will take place and when we are planning a conference call to discuss country-specific procedures/and any questions.

 

REGISTRY SET UP

The Registry will soon be registered on clinicaltrials.gov and the template for the Registry agreement is currently being improved in order to facilitate a non-negotiable agreement which will allow set-up of the registry in a timely manner. More information will be posted soon.

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Sincerely,

The FAST Therapy Trial Team