NCT06510231招募中不适用
Inspiratory Muscle Training in Heart Failure With Preserved Ejection Fraction
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Change in inspiratory muscle blood flow demand
研究概览
简要总结
This study is being done to determine how inspiratory muscle training impacts inspiratory muscle function during exercise in heart failure patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •≥18 yrs of age
- •Receiving SGLT2 inhibitors and spironolactone (and beta-blocker use for HFpEF patients with hypertension) for >3 months
- •NYHA symptoms I-III
- •Body mass index ≤40 kg/m2
- •Currently non-smokers with <20 pack year history
- •Able to exercise (i.e. without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise)
排除标准
- •Sustained ventricular tachycardia and/or ventricular fibrillation within 21 days of visit 1
- •Second or third degree heart block
- •Body mass index >40 kg/m2
- •Current smokers and/or smoking history >20 pack years
- •Pregnant women (testing will be done by research team if requested)
- •Glomerular filtration rate of <30 mL/min/1.73m2 (initial screen via clinical record within the past 6 months and this will be assessed on Visit 1)
- •Individuals who are not able to engage in exercise
- •Uremia, history of allergy to iodides
- •Peripheral artery disease
- •Alanine transaminase and/or aspartate transaminase greater than 2 times the upper limit of normal (via clinical record within the past 6 months)
- •Asthmatic patients with a low symptom perception and suffer frequency, severe exacerbations or with an abnormally low perception of dyspnea
- •Ruptured eardrum or any other condition of the ear
- •History of spontaneous pneumothorax or osteoporosis with a history of rib fractures
- •History of lidocaine allergy.
- •For individuals agreeing to undergo dual energy x-ray absorptiometry (DEXA) scanning for measurement of body composition as part of their study visit, additional exclusion criteria apply: recently administered gastrointestinal contrast or radionuclides; severe degenerative changes or fracture deformity in measurement areas; or inability to attain correct position and/or remain motionless for the measurement period.
研究组 & 干预措施
Inspiratory muscle training (IMT) group
Experimental
IMT performed at 40% maximal inspiratory pressure (MIP) for 30 minutes 7 days a week for 8 weeks.
干预措施: Inspiratory Muscle Training (Other)
SHAM group
Sham Comparator
IMT performed at 2% maximal inspiratory pressure (MIP) for 30 minutes 7 days a week for 8 weeks.
干预措施: Inspiratory Muscle Training (Other)
结局指标
主要结局
Change in inspiratory muscle blood flow demand
时间窗: Baseline, 8 weeks
Inspiratory muscle blood flow demand will be measured via indocyanine green dye venous bolus injection. This will be measured in umol.
次要结局
- Change in locomotor muscle blood flow(Baseline, 8 weeks)
- Change in exercise tolerance(Baseline, 8 weeks)
研究者
Joshua R. Smith
Principal Investigator
Mayo Clinic
研究点 (1)
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