Cardiovascular: asymptomatic aortic stenosis Circulatory System Asymptomatic aortic stenosis
Conditions
Interventions
Factory-prepared randomised packs of identical placebo/ramipril tablets. Initial supply for 2 weeks, then further supply at the second clinic visit, to allow for up-titration of ramipril dose. Randomi
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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 200 mmHg or diastolic blood pressure 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety of administration in this group of patients 2. Changes in left ventricular mass and function | — |
Secondary
| Measure | Time frame |
|---|---|
| Added 21/05/2010: 1. Change in left ventricular ejection fraction 2. Change in other LV functional parameters assessed by MRI 3. Change in biochemical markers of LV function (BNP) 4. Change in myocardial energetics measured with magnetic resonance spectroscopy 5. Time to symptoms of aortic stenosis or aortic valve replacement 6. Change in distance walked and maximal effort tolerance on exercise treadmill testing | — |
Countries
United Kingdom
Outcome results
None listed