Graded Exercise Training for Individualized Treatment in Cardiac Amyloidosis: GET-FIT Cardiac Amyloidosis Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Peak Oxygen Consumption (Peak VO2)
研究概览
简要总结
Numerous clinical trials have demonstrated that transthyretin (TTR)-directed medical therapies can reduce the rate of functional decline in patients with transthyretin cardiac amyloidosis (ATTR-CM). However, patients treated with these therapies often experience a progressive reduction in exercise capacity despite treatment. Further, no randomized controlled trials (RCTs) have assessed the effects of exercise intervention in patients with ATTR-CM receiving TTR-directed therapy.
详细描述
Habitual exercise has been shown to improve longevity and reduce overall mortality. Patients with ATTR-CM routinely experience reduced exercise tolerance and functional capacity as the disease progresses. Cardiopulmonary exercise testing (CPET) is the gold standard for assessing quantitative exercise capacity and cardiorespiratory fitness in clinical testing, and peak oxygen consumption (peak VO2) serves as one of the most powerful prognostic markers in cardiovascular health. Lower peak VO2 values are strongly correlated with adverse cardiac events and mortality in individuals with ATTR-CM, including those on contemporary therapies. While major RCTs assessing TTR silencers and stabilizers have shown a reduction in the rate of decline of functional capacity compared to placebo, patients on active therapy still experience an overall decline in functional status. Existing clinical trials have not investigated the effects of a structured exercise training protocol on preventing this functional decline in patients with ATTR-CM. This study aims to evaluate whether an individualized exercise regimen provides additive improvements in exercise capacity and quality of life for patients with ATTR-CM who are receiving background TTR-directed therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Clinical diagnosis of ATTR-cardiac amyloidosis
- •Able to perform endurance and resistance exercise
- •Currently on stable dose of TTR-directed therapy, if on therapy
- •Adequate clinical stability has been achieved (in the judgment of the investigator) to allow participation in study assessments and intervention.
- •Signed informed consent indicating that the patient understands the purpose of the study, the procedures required and is willing to participate
排除标准
- •Sustained ventricular arrhythmias or ICD shock within 6 months
- •Severe valvular stenosis
- •Pregnancy
- •Recent acute coronary syndrome or coronary artery bypass < 6 months
- •Large pericardial effusion
- •Recent acute myocarditis (< 3 months)
- •Recent cardiac medication changes for management of cardiomyopathy
- •Patients with investigational intracardiac devices
研究组 & 干预措施
Intervention Arm
Participants randomized to the intervention arm will be prescribed a training plan and provided with a gym membership including personal training sessions. Participants will also be given a smartwatch to track activity.
干预措施: Exercise Intervention (Behavioral)
Control Arm
Participants randomized to the control arm will receive a Physical Activity Recommendations Handout and a smartwatch to track activity.
干预措施: Physical Activity Handout (Behavioral)
结局指标
主要结局
Peak Oxygen Consumption (Peak VO2)
时间窗: 12 weeks
CPET performed at baseline and 12-weeks, following the exercise intervention will be used to measure aerobic capacity, peak VO2. The change in peak VO2 from baseline to 12 weeks is the primary outcome measure.
Ventilatory Efficiency (VE/VCO2 Slope)
时间窗: 12 weeks
Ventilatory efficiency is defined as the slope of minute ventilation to carbon dioxide production (VE/VCO2) and will be evaluated via CPET performed at baseline and at 12-weeks. A lower slope indicates improved ventilatory efficiency.
次要结局
- Short Form - 36 (SF-36)(12 weeks)
- Kansas City Cardiomyopathy Questionnaire - Overall Summary (KCCQ-OS)(12 weeks)
- Groningen Frailty Indicator (GFI)(12 weeks)
- Short Physical Performance Battery (SPPB)(12 weeks)
研究者
Bradley Petek
Principal Investigator
Oregon Health and Science University