Graded Exercise Training For Individualized Treatment in Hypertrophic Cardiomyopathy: GET-FIT Hypertrophic Cardiomyopathy 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
Exercise intervention trials in patients with hypertrophic cardiomyopathy (HCM) have demonstrated an association with improvement in resting and exercise hemodynamics, ventricular remodeling, and anxiety/depression. However, no randomized controlled trials (RCTs) to date have assessed the effects of exercise intervention in patients with HCM on cardiac myosin inhibitors (CMIs). This trial aims to evaluate the efficacy of a 12-week individualized exercise training program in HCM patients receiving aficamten.
详细描述
Habitual exercise has been shown to improve longevity and reduce mortality. Patients with HCM often have reduced exercise tolerance as the disease progresses. Cardiopulmonary exercise testing (CPET) is often performed to assess quantitative exercise capacity in clinical testing, but questions remain on normative values and how to accurately predict prognosis in individuals with HCM. Peak oxygen consumption (peak VO2) measured by CPET is the gold standard for assessing cardiorespiratory fitness and is an important prognostic marker in cardiovascular health. Prior RCTs have demonstrated that 12 to 20 weeks of exercise training can safely improve peak VO2, hemodynamics, and quality of life in selected patients with HCM. However, existing exercise trials have not included individuals actively treated with CMIs, which represent an emerging standard of care. Further, these exercise intervention trials have not universally included resistance training, despite recommendations in current guidelines. This study aims to evaluate whether an individualized exercise regimen combining endurance and resistance training provides additive improvements in exercise capacity and quality of life for HCM patients on aficamten.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years.
- •Clinical diagnosis of HCM.
- •Able to perform endurance and resistance exercise.
- •Currently on stable dose of aficamten
- •Not meeting current guideline recommended physical activity recommendations (150-300 minutes of moderate-vigorous physical activity/week, strength training ≥2 times weekly).
- •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
- •Residual left ventricular outflow tract obstruction (peak gradient ≥50mmHg at rest).
- •Sustained ventricular arrhythmias or ICD shock within 6 months.
- •Pregnancy.
- •Severe valvular stenosis.
- •Large pericardial effusion.
- •Recent acute myocarditis (< 3 months).
- •Recent acute coronary syndrome or coronary artery bypass < 6 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 and chest strap to track physical activity.
干预措施: Exercise Intervention (Behavioral)
Control Arm
Participants randomized to the control arm will be receive a Physical Activity Recommendations Handout and a smartwatch to track physical 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
- Kansas City Cardiomyopathy Questionnaire - Overall Summary (KCCQ-OS)(12 weeks)
- Short Form - 36 (SF-36)(12 weeks)
研究者
Bradley Petek
Principal Investigator
Oregon Health and Science University