A randomised controlled trial of the angiotensin converting enzyme inhibitor ramipril in asymptomatic aortic stenosis - Ramipril in aortic stenosis (RIAS)

Phase 1

• Conditions: Aortic stenosis of at least moderate degree (peak velocity >=3.0m/sec or aortic valve area <1.5cm2)

• Registration Number: EUCTR2007-005224-32-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-12
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

•Male or Female, aged 18 years or above.
•Diagnosed with asymptomatic aortic stenosis of at least moderate degree (peak velocity >3.0m/sec; gradient >36mmHg or valve area <1.5cm2 by echocardiography) for whom aortic valve replacement surgery is currently not contemplated.
•Left ventricular ejection fraction on echocardiography >=40% without regional wall motion abnormality suggestive of significant previous myocardial infarction.
•Patient or legal representative is willing and able to give informed consent for participation in the study.
•Able (in the Investigators opinion) and willing to comply with all study requirements.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Other significant valve disease
•Female who is pregnant, lactating or planning pregnancy during the course of the study.
•Significant renal impairment (estimated GFR<30mls/minute). If moderate renal impairment is present (GFR 30-59mls/minute), patients may be included in the study, but will not receive gadolinium contrast during the CMR scan
•Known hepatic impairment (AST/ALT > 2 times the upper limit of normal).
•Prescription of ACE inhibitors or angiotensin II receptor blockers (ARBs) within the 3 months prior to the start of the study
•Past history of an allergic reaction or intolerance to ACE inhibitors.
•Sustained systolic blood pressure <100mmHg or >200mmHg or diastolic blood pressure <40mmHg or >110mmHg at baseline measurement.
•Contraindication to magnetic resonance scanning (pacemaker, cranial aneurysm clips, metallic ocular foreign bodies, severe claustrophobia).
•Patient is terminally ill.
•Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or may influence the result of the study, or the patient ability to participate in the study.
•Patient/subjects who have participated in another research study involving an investigational product in the past 3 months.

Study & Design

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