Avaliação ecocardiográfica do índice de massa ventricular esquerda em crianças com hipospádia após estimulação hormonal com testosterona tópica - um ensaio clínico controlado randomizado

Abstract

Testosterone is often used in the preoperative period of surgery in cases of severe hypospadias. Previous studies have demonstrated the presence of androgen receptors in cardiac myocytes that can modulate the phenotype. The use of supraphysiological doses of androgens can lead to toxicity on the heart muscle and, in some cases, to left ventricular hypertrophy. This randomized double blind controlled clinical trial aims to evaluate the effect of topical testosterone on left ventricular mass index in boys with hypospadias. Boys with hypospadias aged 6 months to 9 years were included. Boys were divided into two groups: G1 - boys who received testosterone propionate 1% ointment twice a day for 30 days, and G2 - boys receiving placebo ointment in the same regimen. All boys were submitted to bidimensional echocardiographic evaluation to compare the left ventricular mass index, blood pressure, and body mass index before treatment, at its ending and 60 days later. Levels of serum testosterone, LH, and FSH were measured. Thirty-five boys were analyzed: 17 in G1 and 18 in G2. No differences were found in left ventricular mass index (left ventricular mass indexed by body surface area) prior to treatment. Left ventricular mass index was 59.21 ± 11.91 g/m² in G1 and 55.12 ± 8.29 g/m² in G2 (p=0.244) at the end of the treatment and 61.13 ± 11.69 g/m² in G1 and 62.84 ± 35.99 g/m² in G2 (p=0.852) 60 days later. Serum testosterone levels were 12[7-80] ng/dL in G1 and 5[5-7] ng/dL in G2 (p=0.018) at the end of the treatment of treatment and 10[5- 11] ng/dL in G1 and 5[4-5] ng/dL in G2 (p=0.155), 60 days later. There was a small increase in systolic blood pressure (SBP) at the end of the treatment (83.82 ± 7.18 mmHg) in the group who receive testosterone (G1) compared with controls (G2), 77.5 ± 6.69 mmHg (p=0.010). Passing 60 days, SBP levels returned to basal levels in G1 (82.35 ± 5.62 mmHg) and in G2 (81.38 ± 4.79 mmHg) (p=0.588). Topical testosterone can be considered safe in the preoperative period of boys with hypospadias with no risk of left ventricular hypertrophy. An increase in systolic blood pressure occurs while using testosterone but it is transitory, returning to normal levels 60 days after the discontinuation of the drug.