A prospective, randomized, double-blind, placebo controlled trial of beta-blockade in patients who have undergone surgical correction of tetralogy of Fallot

• Published in: Cardiology in the young 2007-08, Vol.17 (4), p.372-379
• Main Authors: Norozi, Kambiz, Bahlmann, Jens, Raab, Björn, Alpers, Valentin, Arnhold, Jan O., Kuehne, Titus, Klimes, Katrin, Zoege, Monika, Geyer, Siegfried, Wessel, Armin, Buchhorn, Reiner
• Format: Article
• Language: English
• Subjects: Adolescent; Adrenergic beta-Antagonists - administration & dosage; Adrenergic beta-Antagonists - therapeutic use; Adult; Bisoprolol - administration & dosage; Bisoprolol - therapeutic use; Cardiac failure; clinical trial; Double-Blind Method; Drug Administration Schedule; Exercise Tolerance; Female; Follow-Up Studies; Heart Failure - blood; Heart Failure - drug therapy; Heart Failure - etiology; Humans; Male; Middle Aged; Natriuretic Peptide, Brain - blood; natriuretic peptides; Peptide Fragments - blood; Prospective Studies; Tetralogy of Fallot - blood; Tetralogy of Fallot - complications; Tetralogy of Fallot - surgery; Treatment Outcome
• ISSN: 1047-9511; 1467-1107
• DOI: 10.1017/S1047951107000844

Our purpose was to evaluate the effect of a treatment over six months with bisoprolol on the surrogate parameters of N-Terminal-pro brain natriuretic peptide, subsequently to be described as brain natriuretic peptide, peak uptake of oxygen, and ventricular function assessed by magnetic resonance imaging in grown ups and adults who had undergone surgical correction of tetralogy of Fallot. We designed a prospective, randomized, double-blind, placebo controlled trial. We enrolled 33 patients, aged 30.9 plus or minus 9.5 years in either class 1 or 2 of the grading of the New York Heart Association class with both levels of brain natriuretic peptide greater than 100 pg/ml and a reduced peak uptake of oxygen less than 25 ml/kg/min. During treatment with Bisoprolol, the levels of brain natriuretic peptide increased significantly from 206 plus or minus 95 to 341 plus or minus 250 pg/ml (p< 0.05), and those of atrial natriuretic peptide from 4117 plus or minus 1837 to 5340 plus or minus 2102 fmol/ml (p = 0.0005). These measures remained unchanged in the group of patients receiving the placebo. Peak uptake of oxygen did not differ significantly in either group, nor did treatment have any significant effect on right and left ventricular volumes and ejection fractions as determined by magnetic resonance imaging. The clinical state as judged within the grading system of the New York Heart Association was also unchanged by beta-blockade. Beta blockade with Bisoprolol seems to have no beneficial effect on asymptomatic or mildly symptomatic patients with right ventricular dysfunction secondary to repaired tetralogy of Fallot with residual pulmonary regurgitation and/or stenosis.