Exercise Effect on Transthyretin Stability in Master Athletes and Patients With Transthyretin Amyloidosis
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in percent transthyretin stability assay
研究概览
简要总结
The goal of this study to investigate if exercise predisposes to transthyretin instability. The investigators will evaluate the effect of exercise on transthyretin biochemistry.
详细描述
This is an investigator initiated observational study, designed to study the effect of exercise on transthyretin stability in three main populations: Group 1: healthy master athletes who are 60 years or older. Group 2: Genotype positive (G+) cardiac phenotype negative (P-) patients with variant ATTR (i.e. carriers without evidence of disease). Group 3: Patients with ATTR CA who have not been on a stabilizer (tafamidis) within the last 14 days prior to enrollment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General inclusion criteria: patients should be able to exercise on a treadmill or a bike, willing to consent to the study procedures and willing to return to site during the follow up period of 72 hours for repeated blood and urine collection
- •Specific inclusion criteria:
- •Group 1: Subjects must be at least 60 years of age and meet the master athlete definition of: athletes engaged in cycling ≥8 hours per week or running ≥6 hours per week or triathlon training (combination of swimming, cycling, running) ≥8 hours per week, or equivalent sports activities, for at least 6 months prior to enrollment.
- •Group 2: Genotype positive (G+) cardiac phenotype negative (P-) patients with variant ATTR (i.e. carriers without evidence of disease)
- •Group 3: Patients with ATTR CA who have not been on a stabilizer (tafamidis) within the last 14 days prior to enrollment.
排除标准
- •Taking diflunisal or daily non-steroidal anti-inflammatory drugs (NSAIDs) use within 2 weeks.
结局指标
主要结局
Change in percent transthyretin stability assay
时间窗: Change from baseline to 72 hours post-exercise
Transthyretin stability will be measured and expressed as a percentage
次要结局
- Plasma transthyretin fragments(Change from baseline to 72 hours post-exercise)
- Plasma transthyretin level(Change from baseline to 72 hours post-exercise)
研究者
Ahmad Masri
Principal Investigator
Oregon Health and Science University