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

Published online by Cambridge University Press:  18 June 2007

Kambiz Norozi ,
Jens Bahlmann ,
Björn Raab ,
Valentin Alpers ,
Jan O. Arnhold ,
Titus Kuehne ,
Katrin Klimes ,
Monika Zoege ,
Siegfried Geyer  and
Armin Wessel
...Show all authors
Kambiz Norozi
Affiliation:
Department of Paediatric Cardiology and Intensive Care, Germany
Jens Bahlmann
Affiliation:
Departments of Paediatric Cardiology and Intensive Care, Georg-August-University, Göttingen, Germany
Björn Raab
Affiliation:
Department of Radiology, Georg-August-University, Göttingen, Germany
Valentin Alpers
Affiliation:
Departments of Paediatric Cardiology and Intensive Care, Georg-August-University, Göttingen, Germany
Jan O. Arnhold
Affiliation:
Departments of Paediatric Cardiology and Intensive Care, Georg-August-University, Göttingen, Germany
Titus Kuehne
Affiliation:
Departments of Congenital Heart Disease and Paediatric Cardiology, German Heart Institute, Berlin, Germany
Katrin Klimes
Affiliation:
Departments of Congenital Heart Disease and Paediatric Cardiology, German Heart Institute, Berlin, Germany
Monika Zoege
Affiliation:
Medical Sociology Unit, Medical School Hannover, Germany
Siegfried Geyer
Affiliation:
Medical Sociology Unit, Medical School Hannover, Germany
Armin Wessel
Affiliation:
Department of Paediatric Cardiology and Intensive Care, Germany
Reiner Buchhorn*
Affiliation:
Departments of Paediatric Cardiology and Intensive Care, Georg-August-University, Göttingen, Germany
*
Correspondence to: Reiner Buchhorn, Director of the Department of Paediatrics, Caritas Hospital, Bad Mergentheim, Uhlandstr. 7, 97980 Bad Mergentheim, Germany. Tel: +49 07931 58 2301; Fax: +49 07931 58 2390; E-mail: [email protected]
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Abstract

Aims

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.

Methods and 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.

Conclusion

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.

Keywords

Cardiac failurenatriuretic peptidesclinical trial
Type
Original Article
Information
Cardiology in the Young , Volume 17 , Issue 4 , August 2007 , pp. 372 - 379
Copyright
Copyright © Cambridge University Press 2007

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