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临床试验/ACTRN12623000165684
ACTRN12623000165684尚未招募4 期

Evaluating Testosterone Therapy to Prevent Heart Failure in Women: The ETHEL study.

Monash University0 个研究点目标入组 38 人开始时间: 2023年2月17日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
入组人数
38

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
60 Years 至 o limit(—)
性别
Female

入选标准

  • Evidence of Stage B heart failure with reduced functional capacity (<85% age-predicted VO2peak).
  • - Normal mammogram within the preceding 2 years

排除标准

  • - Heart failure, either documented or undiagnosed with an EF <40% or NTproBNP >400ng/L
  • - Other cardiac disease (myocardial infarction, angina; known coronary artery disease; valve disease more than moderate)
  • - Features incompatible with the study design (unlikely to be adherent to follow-up; <12 months life expectancy due to concomitant disease; participation in another clinical trial where blinded treatment would be unacceptable; unable to provide written informed consent)
  • - Inability to acquire interpretable echo images (uncommon)
  • - Unstable diabetes (HbA1C>7.5%)
  • - Estrogen-sensitive cancer
  • - Use of any drugs or dietary supplements that may affect testosterone effects including, but not limited to systemic antiandrogen therapy (spironolactone; cyproterone acetate; finasteride; minoxidil)
  • - Treatment with SGLT-2 inhibitors or GLP-1 agonists as indicated
  • - Recent use of androgen therapy
  • - Contraindication to exercise
  • - Inability to speak or understand English

研究者

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