PAS Pilot Trial
Research type
Research Study
Full title
Prevention of Aortic Stenosis Pilot Trial
IRAS ID
159481
Contact name
David Wald
Contact email
Sponsor organisation
Queen Mary University of London
Eudract number
2015-000704-25
Duration of Study in the UK
1 years, 3 months, 27 days
Research summary
A randomised placebo controlled crossover pilot trial of the phosphate binding drug sevelamer, at doses of 2.4g/day and 7.2g/day will be compared with placebo in patients with aortic stenosis. The trial is expected to determine if treatment reduces phosphate levels and whether there is a difference in effect between the low and high doses. The intention is to allocate participants in random sequence to about a 6 week period of taking sevelamer 2.4g/day, about a 6 week period of taking 7.2g/day and about a 6 week period of taking placebo. The intention is to assess blood and urine phosphate at the end of each treatment period. The intended sample size is 54 to 72 depending on non-completion. Allowing for an approximate 25% non-completion rate, a trial of 72 participants has at least 80% power to show a reduction in serum phosphate of 0.5mg/dL or greater (SD for change 1.3mg/dL) at the 5% level of statistical significance. Participants will be identified within NHS sites. Consent will be sought either at the NHS site (Participant Identification centre) at which the participants receive their clinical care, if the participants prefer to be seen there (since this will be a familiar environment) or at the Wolfson Institute of Preventive Medicine, where follow-up visits will be undertaken. Consent will be sought by the PI or an appropriately trained delegated researcher.
REC name
London - Westminster Research Ethics Committee
REC reference
17/LO/0120
Date of REC Opinion
24 Feb 2017
REC opinion
Further Information Favourable Opinion