Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr R Steeds


Contact details

Selly Oak Hospital
B29 6JD
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Medical management of severe aortic regurgitation in asymptomatic patients with normal left ventricular function with valsartan -a study to assess disease progression


Study hypothesis

Treatment with valsartan reduces the adaptive increase in LV mass to chronic moderate-severe AR in asymptomatic patients (NYHA II or less) with normal EF >50% and preserved LV dimensions (LVIDs less than 5.5cm) to a greater extent than short-acting nifedipine.

Updated 06/03/2015: the trial was stopped due to lack of recruitment.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Cardiovascular: Severe Aortic Regurgitation


Patients will be randomised in a single blind fashion to Valsartan 80 mg twice daily or modified release nifedipine 20 mg bd continued for one year.

In all patients at entry, a full clinical assessment will be performed and clinical details including cause of AR, presence of vascular disease, risk factors for vascular disease and drug therapy will be recorded. Blood pressure, heart rate and body mass index will be recorded. NYHA and CSA status will be recorded. A 12 lead ECG will be recorded. Routine haematological and biochemical parameters including plasma lipids will be recorded. Renal function will be measured at two weeks following randomisation. If creatinine has risen by more that 10% or >150 micromol/l or potassium >5.9 mmol/l then the study drug will be withdrawn. Exercise capacity will be assessed using the six minute walk test. At baseline, the following measurements will be made:

LV mass, LV volumes and LV function will be calculated using serial contiguous short axis TrueFISP cine sequences with 7 mm slice thickness and 3 mm gap using a 1.5-Tesla magnet as previously described (Bellenger and Pennell 2002). Analysis will be performed off-line using the semi-automated Siemens ARGOS software. In addition, regurgitant fraction and regurgitant volumes will be calculated from LV and RV volumetric analysis, together with velocity-encoded flow mapping.

The following parameters will be obtained:
Assessment of AR:
- Regurgitant jet size on CF Doppler (%LVOT)
- Vena contracta
- PISA radius and effective orifice quantification
- Diastolic jet deceleration (pressure half-time)
- Regurgitant fraction by stroke volume (AV / PV)
- Doppler flow reversal aorta
- Subjective assessment
LV mass (ASE): 0.80 . 1.05 . [(IVS+PW+LVID)3 - LVID3]
LV systolic (and diastolic) function:
- LVEF by modified Simpsons rule
- Tei index

Clinical, biochemical, echo and CMR assessment will be repeated at 12 months.

Intervention type



Not Applicable

Drug names

Valsartan, nifedipine

Primary outcome measure

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 outcome measures

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

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)

Participant recruitment issue


Participant 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 <2)
2. Normal LVEF >50%
3. Preserved LV dimensions (LVIDs <5.5cm)

Participant type


Age group

Not Specified


Not Specified

Target number of participants

Not provided at time of registration

Participant 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 (<50 percent)
5. Contra-indications to Angiotensin II receptor antagonist therapy (previous intolerance; known or suspected renovascular hypertension; creatinine >150 umol/L, serum potassium > 5.9 mmol/l) or to treatment with nifedipine
6. Contra-indication to cardiac MRI

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Selly Oak Hospital
B29 6JD
United Kingdom

Sponsor information


Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
United Kingdom
+44 (0)207 307 2622

Sponsor type




Funder type

Hospital/treatment centre

Funder name

University Hospital Birmingham NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes