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

Completed

• Conditions: Cardiovascular: asymptomatic aortic stenosis; Circulatory System; Asymptomatic aortic stenosis

• Registration Number: ISRCTN24616095
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Added 21/05/2010:
1. Male or female, aged 18 years or above
2. Diagnosed with asymptomatic aortic stenosis of at least moderate degree (peak velocity =3.0 m/sec; gradient =36 mmHg or valve area <1.5 cm2 by echocardiography) for whom aortic valve replacement surgery is currently not contemplated
3. Left ventricular ejection fraction on echocardiography =40% without regional wall motion abnormality suggestive of significant previous myocardial infarction
4. Patient is willing and able to give informed consent for participation in the study
5. Able (in the investigators' opinion) and willing to comply with all study requirements

Exclusion Criteria

Added 21/05/2010:
1. Other significant valve disease
2. Female who is pregnant, lactating or planning pregnancy during the course of the study
3. Significant renal impairment (estimated GFR < 30 ml/min). If moderate renal impairment (GFR 30-59 ml/min) is present, patients may be included in the study, but will not receive gadolinium contrast during the CMR scan
4. Known hepatic impairment (AST/ALT > 2 times the upper limit of normal)
5. Prescription of ACE inhibitors or angiotensin II receptor blockers (ARBs) within the 3 months prior to the start of the study
6. Past history of an allergic reaction or intolerance to ACE inhibitors
7. Sustained systolic blood pressure <100 mmHg or >200 mmHg or diastolic blood pressure <40 mmHg or >110 mmHg at baseline measurement
8. Contraindication to magnetic resonance scanning (pacemaker, cranial aneurysm clips, metallic ocular foreign bodies, severe claustrophobia)
9. Patient is terminally ill
10. 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
11. Patients who have participated in another research study involving an investigational product in the past 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified