Echocardiographic evaluation of left ventricular mass index in children with hypospadias after hormonal stimulation with topical testosterone - A randomized controlled trial
Elisabeth C. Andrade, M.S.1, Victor P. Paschoalin, Ph.D.2, Kelly C. Paiva, M.S.1, Sara S. Guedes, B.S.1, Priscila M. Queiroz, B.S.1, Maira F. Almeida, B.S.1, Mariana L. Souza, medicine student1, Marina N. Pereira, medicine student1, José Bessa, Jr., Ph.D.2, José M. Netto, Ph.D.1.
1Federal University of Juiz de Fora, Juiz de Fora, Brazil, 2State University of Feira de Santana, Feira de Santana, Brazil.
This randomized double blind controlled clinical trial aims to evaluate the effect of topical testosterone on left ventricular mass index in boys with hypospadias. The testosterone ointment is routinely used in the preoperative period of the corrective surgery. Previous studies demonstrated the presence of androgen receptors in cardiac myocytes that can modulate the phenotype and produce cardiac hypertrophy. The effects of androgens on the heart muscle in supraphysiological doses and toxicity were observed, causing evident left ventricular hypertrophy.
Boys with hypospadias aged 6 months to 9 years 11 months and 29 days were included. Children were divided in two groups: G1 - boys who receive testosterone propionate 1% twice a day for 30 days and G2 - boys receiving placebo cream in the same regiment. All children were submitted to bi-dimensional echocardiographic evaluation to compare the left ventricular mass index, blood pressure, body mass index before and after treatment (30 and 90 days). Levels of serum testosterone, LH and FSH were measured.
Twenty-four children were included in the study, being 11 in G1 and 13 in G2. No difference were found in left ventricular mass index (left ventricular mass indexed by body surface area), there was a difference smaller than expected between the two groups, and it was not statistically significant. The left ventricular mass index was 58.8 ± 13.7 g/m² in G1 and 55.6 ± 9.4 g/m² in G2 (p = 0.513) after 30 days of the beginning of the ointment and 62.25 ± 11.6 g/m² in G1 and 55.4 ± 10.25 g/m² in G2 (p = 0.143) after 90 days. Serum testosterone levels were 5.0 ± 2.2 ng/dL in G1 and 61.4 ± 100.1 ng/dL in G2 (p = 0.055) after 30 days of the beginning of the ointment and, after 90 days, 4.7 ± 2 7 ng/dL in G1 and 37.9 ± 79.0 ng/dL in G2 (p = 0.142). It was not statistically significant. There was an small increase in systolic blood pressure after 30 days, 84.09 ± 7.3 mmHg in the group who receive testosterone (G1) and 78.08 ± 5.6 mmHg in G2 (p = 0.033). After 90 days, the levels returned to normal, 82.27 ± 6.4 mmHg in G1 and 81.15 ± 5.0 mmHg in group 2 (p =0.639).
Topical testosterone can considered a safe drug in the preoperative period of children with hypospadias with no risk of left ventricular hypertrophy.
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