title: A prospective, randomized, double-blind, placebo controlled trial of beta-blockade in patients who have undergone surgical correction of tetralogy of Fallot.
abstract: OBJECTIVE
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Paediatric Cardiology and Intensive Care, Germany.
authors.forename: Kambiz
authors.initials: K
authors.lastname: Norozi
authors.forename: Jens
authors.initials: J
authors.lastname: Bahlmann
authors.forename: Björn
authors.initials: B
authors.lastname: Raab
authors.forename: Valentin
authors.initials: V
authors.lastname: Alpers
authors.forename: Jan O
authors.initials: JO
authors.lastname: Arnhold
authors.forename: Titus
authors.initials: T
authors.lastname: Kuehne
authors.forename: Katrin
authors.initials: K
authors.lastname: Klimes
authors.forename: Monika
authors.initials: M
authors.lastname: Zoege
authors.forename: Siegfried
authors.initials: S
authors.lastname: Geyer
authors.forename: Armin
authors.initials: A
authors.lastname: Wessel
authors.forename: Reiner
authors.initials: R
authors.lastname: Buchhorn
mesh_terms: D000293:Adolescent; D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D017298:Bisoprolol / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D017079:Exercise Tolerance; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D020097:Natriuretic Peptide, Brain / Q000097:blood; D010446:Peptide Fragments / Q000097:blood; D011446:Prospective Studies; D013771:Tetralogy of Fallot / Q000097:blood / Q000150:complications / Q000601:surgery*; D016896:Treatment Outcome
chemical_list: D000319:Adrenergic beta-Antagonists; D010446:Peptide Fragments; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain; D017298:Bisoprolol