A randomised cross-over study of effects of vasodilator treatment on left ventricular mass and volume in patients with chronic aortic regurgitation

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000753055

Acronym

No acronym

Enrollment

Registered

2010-09-10

Start date

2010-10-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to determine whether vasodilators, a type of blood pressure treatment, will improve heart function in persons with leaking of the aortic valve. Our hypothesis is that lowering blood pressure will reduce the work of the heart, and over time the volume and thickness of the muscle of the heart's main pumping chamber will improve.

Interventions

Open label oral vasodilator treatment with dose adjusted according to blood pressure and patient tolerance. Perendopril (2 to 8mg daily) candesartan (4 to 32 mg daily)and/or amlodipine (2.5 to 10mg daily). Either one or a combination of these treatments will be administered to achieve a reduction in blood pressure and adjusted according to tolerance and blood pressure, and continued for one year

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Moderate or severe asymptomatic aortic regurgitation

Exclusion criteria

current indication for aortic valve replacement other clinically significant cardiac disease contraindication to cardiac magnetic resonance imaging atrial fibrillation

Outcome results