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Controlled release metoprolol for aortic regurgitation: A double blind, randomised controlled
trial of efficacy and safety
Running head: Metoprolol for aortic regurgitation
Broch, K1,6; Urheim, S1,2; Lønnebakken, MT4,5; Stueflotten, W 1; Massey, R1; Fosså, K3; Hopp, E3;
Aakhus, S1; Gullestad, L1,6
The two first authors contributed equally to this work
1Department
of Cardiology, 2Institute for Surgical Research, and 3Department of Radiology and
Nuclear medicine, Oslo University Hospital Rikshospitalet, Oslo; 4University of Bergen, Department of
Clinical Science, and 5Haukeland University Hospital, Department of Heart Disease, Bergen, Norway;
and 6K. G. Jebsen Cardiac Research Centre and Center for Heart Failure Research, Faculty of
Medicine, University of Oslo, Norway
ABSTRACT
Objective: Chronic aortic regurgitation creates a volume load on the left ventricle, which induces
adaptive responses. With time, excessive left ventricular dilatation may precipitate heart failure unless
aortic valve surgery is performed. Treatment with β-adrenergic receptor antagonists (β-blockers) is
beneficial in patients with heart failure, but the effect of β-blocker therapy in aortic regurgitation is
unclear. This trial was designed to evaluate the effect of controlled release metoprolol on left
ventricular remodelling in patients with chronic aortic regurgitation.
Methods: In this randomised, double blind, placebo-controlled trial, 75 asymptomatic patients with
moderate to severe chronic aortic regurgitation were randomised to receive metoprolol CR/XL uptitrated to 200 mg/day, or matching placebo. The primary end point was left ventricular end diastolic
volume, measured by magnetic resonance imaging after 6 months of treatment.
Results: After 6 months, there was no difference in the baseline-adjusted left ventricular end diastolic
volume between patients allocated to metoprolol and those allocated to placebo. At follow-up, the
mean adjusted left ventricular ejection fraction was 2.7 percentage points (0.1 – 5.3 percentage points;
p = 0.04) higher in the metoprolol group than in the placebo group. The exercise capacity and peak
oxygen consumption did not differ between treatment arms; whereas, serum levels of N-terminal proB-type natriuretic peptide were higher in the metoprolol group. There were no serious adverse events
in either treatment arm.
Conclusions: Treatment with controlled release metoprolol for 6 months did not reverse, nor
exacerbate left ventricular remodelling in patients with moderate to severe aortic regurgitation.