Condition category
Circulatory System
Date applied
13/06/2017
Date assigned
13/06/2017
Last edited
14/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Aortic stenosis is a serious heart condition with no known means of prevention. It is caused by the build up of calcium (a mineral found in the blood) on the aortic valve (flaps of tissue which regulates blood flow) leading to obstruction of blood flow from the heart. Death follows symptoms of heart failure in most cases unless the valve is surgically replaced. The aim of this study is to determine the effect of the drug sevelamer on blood phosphate levels with a view to using this in the prevention of aortic stenosis.

Who can participate?
Adults aged 18 to 90 with mild to moderate aortic stenosis

What does the study involve?
All participants have two periods taking sevelamer (a different dose in each period) and a period taking a placebo (a dummy pill), each period lasting 6 weeks (18 weeks overall). The sequence of treatments and placebo is allocated at random. Blood and urine phosphate levels are measured at the end of each period.

What are the possible benefits and risks of participating?
This study is the first step in determining whether the progression of aortic stenosis can be prevented using sevelamer. This will help guide future medical practice both in the management of the aortic stenosis of patients participating in the study and other people with the same condition. Some people may experience side effects which are reversible on stopping treatment. These tend to be symptoms affecting the gut such as abdominal discomfort, belching, bloating, constipation, diarrhea, and feeling of fullness after eating. Major side effects are extremely rare.

Where is the study run from?
The Wolfson Institute of Preventive Medicine in London is the coordinating centre for the study where all study-related activities take place once patients have given their consent to be in the study. Patients are initially identified from two hospitals: St Bartholomew’s Hospital and St Thomas’ Hospital (UK)

When is the study starting and how long is it expected to run for?
June 2017 to September 2018

Who is funding the study?
Medical Research Council (UK)

Who is the main contact?
Professor David Wald

Trial website

Contact information

Type

Public

Primary contact

Prof David Wald

ORCID ID

Contact details

Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom

Additional identifiers

EudraCT number

2015-000704-25

ClinicalTrials.gov number

Protocol/serial number

PAS01

Study information

Scientific title

Prevention of Aortic Stenosis pilot trial: a randomised cross-over trial

Acronym

PAS Pilot Trial

Study hypothesis

The aim of this study is to assess the efficacy of sevelamer in lowering serum phosphate in patients with aortic stenosis.

Ethics approval

Westminster Research Ethics Committee, 24/02/2017, ref: 17/LO/0120

Study design

Randomised placebo-controlled double blind cross-over trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Aortic stenosis

Intervention

All participants in the study will have two periods taking sevelamer (a different dose in each period) and a period taking a placebo (a dummy pill), each period lasting six weeks (18 weeks overall). The sequence of treatments and placebo will be allocated at random. There are no off-treatment washout periods because the treatment period (6 weeks) is long enough for the effect of the previous treatment to have washed out by the end of each treatment period.

1. 800mg sevelamer three times a day (low dose)
2. 2.4g sevelamer three times a day (standard dose)
3. Placebo three times a day

Intervention type

Drug

Phase

Phase II

Drug names

Sevelamer

Primary outcome measures

Serum phosphate, measured using standard methods for lab analysis at baseline, 6, 12 and 18 weeks

Secondary outcome measures

Urine phosphate, measured using standard methods for lab analysis at 6, 12 and 18 weeks

Overall trial start date

15/06/2017

Overall trial end date

15/09/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aortic stenosis (Vmax 2.0-4.0 m/s)
2. Age 18-90

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

54-72

Participant exclusion criteria

1. Contraindications, including a history of allergy to sevelamer, a history of hypophosphataemia or a history of bowel obstruction
2. A requirement for phosphate binding drugs for other reasons
3. A requirement for drugs that interact with phosphate binding drugs
4. A history of lactose intolerance
5. Any illness judged to contra-indicate participation in the trial
6. Pregnant or breastfeeding women

Recruitment start date

15/06/2017

Recruitment end date

15/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom

Trial participating centre

St Bartholomew's Hospital
West Smithfield
London
EC1A 7BE
United Kingdom

Trial participating centre

St Thomas' Hospital
Westminster Bridge Road Lambeth
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Queen Mary University of London

Sponsor details

Joint Research Management Office (JRMO)
Queen Mary Innovation Centre
Lower Ground Floor
5 Walden Street
London
E1 2EF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Plan is to publish in a peer-reviewed journal around one year from end of trial.

IPD sharing statement
Pseudoanonymised trial data stored in secure Safe Haven repository at Centre for Environmental and Preventive Medicine. Data requests to Prof. David Wald (custodian).

Intention to publish date

15/09/2019

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes