Internal Medicine, All India Institute of Medical Sciences-Rishikesh, Rishikesh, Uttarakhand, India
Internal Medicine, All India Institute of Medical Sciences-Rishikesh, Rishikesh, Uttarakhand, India.
BMJ Open. 2022 May 31;12(5):e056994. doi: 10.1136/bmjopen-2021-056994.
Heart failure is a major contributor to morbidity and mortality in the geriatric population, with no promising therapy currently available with considerable benefit. Testosterone therapy is an emerging viable treatment option given its beneficial effects, including improving cardiac functional capacity, alleviating symptoms and low cost, among others.
We have planned an open-label, parallel design, 1:1 randomised controlled trial, which aims to recruit 986 adult males above the age of 60 diagnosed with chronic stable heart failure fulfilling the eligibility criteria. The participants will be randomised into 2 groups of 493 each. Both groups will receive standard recommended treatment regimen of chronic stable heart failure and intervention arm participants will receive additional testosterone gel. All participants will be assessed at baseline, 4 weeks, 6 weeks and 12 weeks. The primary endpoints will assess the differences in functional capacity, frailty and quality of life at 3 months compared with baseline. The secondary endpoints will include the mean change from baseline at 3 months in cardiac remodelling using echocardiography, serum brain natriuretic peptide levels, the incidence of adverse drug reaction.
The data will be analysed with the help of SPSS 23 software. Primary objectives of change in 6-minute walk test, frailty index and quality of life will be analysed using the student's t-test. The statistical significance will be defined as p value<0.05 and taking confidence level as 95%.
Institutional Ethics Committee clearance taken via letter no AIIMS/IEC/20/847, dated 21 November 2020. This study involves human participants and was approved by institutional ethical committee, DHR Reg: EC/NEW/Inst/2020/1046CDSCO, Reg No: ECR/736/Inst/UK/2015/RR-18. Participants gave informed consent to participate in the study before taking part.
(CTRI)-REF/2020/12/030292.
心力衰竭是老年人群发病率和死亡率的主要原因，目前尚无有前景的治疗方法，且益处有限。由于其有益作用，包括改善心脏功能能力、缓解症状和低成本等，睾酮治疗是一种新兴的可行治疗选择。
我们计划进行一项开放标签、平行设计、1:1 随机对照试验，该试验旨在招募 986 名年龄在 60 岁以上、符合入选标准的诊断为慢性稳定型心力衰竭的成年男性。参与者将被随机分为两组，每组 493 人。两组均接受慢性稳定型心力衰竭标准推荐治疗方案，干预组参与者将额外接受睾酮凝胶治疗。所有参与者将在基线、4 周、6 周和 12 周进行评估。主要终点将评估与基线相比，3 个月时功能能力、虚弱和生活质量的差异。次要终点将包括 3 个月时使用超声心动图评估心脏重构的平均变化、血清脑钠肽水平、药物不良反应发生率。
将使用 SPSS 23 软件分析数据。使用学生 t 检验分析 6 分钟步行试验、虚弱指数和生活质量的变化的主要目标。统计显著性定义为 p 值<0.05，置信水平为 95%。
通过 letter no AIIMS/IEC/20/847，于 2020 年 11 月 21 日获得机构伦理委员会批准。本研究涉及人类参与者，得到了机构伦理委员会的批准，DHR Reg: EC/NEW/Inst/2020/1046CDSCO，Reg No: ECR/736/Inst/UK/2015/RR-18。参与者在参与研究前已签署知情同意书。
（CTRI）-REF/2020/12/030292。
