Navarro-Peñalver Marina, Perez-Martinez M Teresa, Gómez-Bueno Manuel, García-Pavía Pablo, Lupón-Rosés Josep, Roig-Minguell Eulalia, Comin-Colet Josep, Bayes-Genis Antoni, Noguera Jose A, Pascual-Figal Domingo A
1 Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain.
2 Hospital Universitario Puerta del Hierro, Madrid, Spain.
J Cardiovasc Pharmacol Ther. 2018 Nov;23(6):543-550. doi: 10.1177/1074248418784020. Epub 2018 Jun 21.
Testosterone deficiency is associated with heart failure (HF) progression and poor prognosis. Testosterone therapy has been shown to improve exercise capacity in patients with chronic HF, but no trial has evaluated the impact of replacement in patients with demonstrated testosterone deficiency.
Prospective, randomized, double-blind, placebo-controlled, and parallel-group trial comparing testosterone replacement with placebo in males with chronic HF with reduced ejection fraction (HFrEF) and testosterone deficiency (NCT01813201). Long-acting undecanoate testosterone at a fixed dose of 1000 mg was supplied by intramuscular injection at inclusion and then every 3 months. The placebo group received isotonic saline serum. Patients were randomly allocated 1:1 to testosterone or placebo while receiving optimal medical therapy, and the study was conducted for 12 months.
The final sample comprised 29 patients, 15 in the placebo group and 14 in the testosterone group (aged 65 ± 8, 62% with an ischemic etiology, left ventricular ejection fraction [LVEF] 30% ± 6%, 69% New York Heart Association functional [NYHA II]). After 12 months, testosterone replacement increased testosterone levels ( P = .002) but was not associated with benefit in terms of clinical symptoms and functional capacity including NYHA class, Framingham score, Minnesota Living Heart Failure Questionnaire, 6-minute walk test, or LVEF and N-terminal pro-B-type natriuretic peptide levels. No significant side effects associated with testosterone treatment were observed. No effects were found in other hormonal, metabolic, and bone turnover biomarkers.
In patients with HFrEF and testosterone deficiency, replacement therapy was not associated with any significant improvement.
睾酮缺乏与心力衰竭（HF）进展及不良预后相关。睾酮治疗已被证明可改善慢性HF患者的运动能力，但尚无试验评估睾酮缺乏患者进行替代治疗的影响。
一项前瞻性、随机、双盲、安慰剂对照的平行组试验，比较睾酮替代治疗与安慰剂对射血分数降低的慢性HF（HFrEF）且睾酮缺乏男性患者的疗效（NCT01813201）。入选时肌肉注射固定剂量1000mg的长效十一酸睾酮，之后每3个月注射一次。安慰剂组接受等渗盐水血清。患者在接受最佳药物治疗的同时按1:1随机分配至睾酮组或安慰剂组，研究持续12个月。
最终样本包括29例患者，安慰剂组15例，睾酮组14例（年龄65±8岁，62%有缺血性病因，左心室射血分数[LVEF]30%±6%，69%为纽约心脏协会心功能分级[NYHA II级]）。12个月后，睾酮替代治疗可提高睾酮水平（P = 0.002），但在临床症状和功能能力方面未显示出益处，包括NYHA分级、弗雷明汉评分、明尼苏达生活心力衰竭问卷、6分钟步行试验，或LVEF及N末端B型利钠肽原水平。未观察到与睾酮治疗相关的显著副作用。在其他激素、代谢和骨转换生物标志物方面未发现影响。
在HFrEF且睾酮缺乏的患者中，替代治疗未带来任何显著改善。
