Cardiovascular: Severe Aortic Regurgitation Circulatory System Severe Aortic Regurgitation
Conditions
Interventions
Patients will be randomised in a single blind fashion to Valsartan 80mg twice daily or modified release nifedipine 20mg bd continued for one year.
In all patients at entry, a full clinical assessment
Sponsors
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Eligibility
Inclusion criteria
Inclusion criteria: Subjects are to be recruited from patients either under active follow-up or active referral as in-patients or out-patients to the Department of Cardiology, University Hospital Birmingham. Inclusion criteria: 1. Asymptomatic or mildly symptomatic patients with moderate - severe AR (NYHA II or less; CSA 50% 3. Preserved LV dimensions (LVIDs <5.5cm)
Exclusion criteria
Exclusion criteria: 1. Acute, severe AR or rapid deterioration of AR (within the preceding six months) 2. Mixed aortic stenosis and regurgitation (valve stenosis > mild defined as peak gradient above 20 mm Hg) 3. Evidence of additional valvular or congenital heart disease on echocardiographic study sufficient to require surgical intervention 4. Abnormal left ventricular ejection fraction (150 umol/L, serum potassium > 5.9 mmol/l) or to treatment with nifedipine 6. Contra-indication to cardiac MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end-point will be a comparison in the reduction in LV mass assessed with cardiac MR at one year between Valsartan 80mg bd and modified release nifedipine 20mg bd. Quality of measurement will be enhanced by assessment by two independent assessors at different sittings. Studies will be performed to confirm inter- and intra-observer variability of assessments. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in LV ejection fraction 2. Change in LV volume 3. Change in regurgitant fraction 4. Reduction in progression to the combined end-point of symptoms (NYHA >II) 5. LV systolic dysfunction (LVEF<50%) 6. Requirement for AVR 6. Death over the study period | — |
Countries
United Kingdom
Outcome results
None listed