Prevention of aortic stenosis pilot trial
| ISRCTN | ISRCTN17365679 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17365679 |
| EudraCT/CTIS number | 2015-000704-25 |
| Secondary identifying numbers | PAS01 |
- Submission date
- 13/06/2017
- Registration date
- 13/06/2017
- Last edited
- 12/09/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Public
Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom
Study information
| Study design | Randomised placebo-controlled double blind cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Prevention of Aortic Stenosis pilot trial: a randomised cross-over trial |
| Study acronym | PAS Pilot Trial |
| Study objectives | The aim of this study is to assess the efficacy of sevelamer in lowering serum phosphate in patients with aortic stenosis. |
| Ethics approval(s) | Westminster Research Ethics Committee, 24/02/2017, ref: 17/LO/0120 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Sevelamer |
| Primary outcome measure | 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 study start date | 15/06/2017 |
| Completion date | 15/09/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 54-72 |
| Total final enrolment | 72 |
| Key inclusion criteria | 1. Aortic stenosis (Vmax 2.0-4.0 m/s) 2. Age 18-90 |
| Key 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 |
| Date of first enrolment | 15/06/2017 |
| Date of final enrolment | 15/06/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
EC1M 6BQ
United Kingdom
London
EC1A 7BE
United Kingdom
Lambeth
London
SE1 7EH
United Kingdom
Sponsor information
University/education
Joint Research Management Office (JRMO)
Queen Mary Innovation Centre
Lower Ground Floor
5 Walden Street
London
E1 2EF
England
United Kingdom
"ROR" |
https://ror.org/026zzn846 |
|---|
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 15/09/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Plan is to publish in a peer-reviewed journal around one year from end of trial. |
| IPD sharing plan | Pseudoanonymised trial data stored in secure Safe Haven repository at Centre for Environmental and Preventive Medicine. Data requests to Prof. David Wald (custodian). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2019 | 12/09/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
12/09/2019: Publication reference and total final enrolment added.
