Prevention of Aortic Stenosis pilot trial

Phase 1

• Conditions: Aortic Stenosis. It is caused by the build-up of calcium phosphate crystals on the aortic valve (aortic sclerosis). Progressive valve narrowing (stenosis) leads to symptoms (chest pain, syncope or heart failure) and either death or surgical valve replacement in the majority of symptomatic cases.; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-000704-25-GB
• Lead Sponsor: Queen Mary University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-25
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

Patients invited to participate in the trial will be men and women aged 18 to 90 with mild to moderate aortic stenosis defined according to a peak trans-aortic valve doppler gradient of 2.0-4.0m/s.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 62

Exclusion Criteria

Exclusions include
1)Any inclusion not met.
2) Contraindications, including a history of allergy to sevelamer, a history of hypophosphataemia or a history of bowel obstruction
3) a requirement for phosphate binding drugs for other reasons
4) a requirement for drugs that interact with phosphate binding drugs
5) A history of lactose intolerance
6) any illness judged to contra-indicate participation in the trial
7) pregnant or breast feeding women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: To determine the within-person differences in serum phosphate after taking sevelamer at 2.4g/day and 7.2g/day compared with placebo.<br> ;Secondary Objective: To assess urine phosphate, side-effects and adherence. ;Primary end point(s): to determine the within-person differences in serum phosphate concentration after taking sevelamer at 2.4g/day and 7.2g/day compared with placebo.;Timepoint(s) of evaluation of this end point: At the end of each 6 week treatment period.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): To determine the within-person differences in urine phosphate concentration after taking sevelamer at 2.4g/day and 7.2g/day compared with placebo.<br> Side-effects assessed by symptom reporting Questionnaire<br> Adherence assessment by pill counts.<br> ;Timepoint(s) of evaluation of this end point: At the end of each 6 week treatment period.