Parasympathetic Augmentation Via Respiratory Training for Patients With Systolic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Change from baseline to 6 months for the 6-minute walk test (6MWT)
研究概览
简要总结
This is a prospective, randomized, controlled clinical trial in which participants with NYHA class II or III and symptomatic Heart Failure with reduced Ejection Fraction (HFrEF) (Ejection Fraction (EF) ≤ 45%) will be assigned to one of two treatment groups: standard of care or breathing therapy.
详细描述
To evaluate the effect of breathing training on the 6-minute walk test in a population of heart failure patients.
Enrollment/Baseline Visit During the enrollment visit, the participant will meet with the clinical research coordinator (CRC) to review any final questions regarding the study and the informed consent form will be signed. The enrollment visit must occur within one month of screening. Once the informed consent is signed, the following procedures will occur.
- Randomization: Participants will be randomized using REDCap in a 2:1 blocking method into the intervention group (breathing therapy) or the control (standard of care).
- N-terminal (NT)-pro hormone BNP (NT-proBNP): If an NT-proBNP was collected as standard of care within 3 months of enrollment, this can be used for study purposes and compared to the 6 month NT-proBNP.
- New York Heart Association Class: If the NYHA class is completed as standard of care within 3 months of enrollment, this can be used for study proposes.
- Kansas City Cardiomyopathy Questionnaire (KCCQ)
- Respiratory Rate
- Peak Expiratory Flow
- 6-minute walk test
- Orientation to the Heart Rate Variability 4 (HRV4) Training application: This will include downloading, creating an account for, and training the participant on the application.
The Intervention Group will also receiving training on the Meo Health breathing therapy, which will include:
- Being shown the Meo Health Breathing Therapy On-Boarding video
- Orientation to breathing application: Participants will be assisted in downloading and custom setting the Breathe application.
- Zoom Within one month of the baseline visit, participants in the intervention group will have a one-on-one training session with the Meo Health breathing coach. This will mark the beginning of their breathing therapy intervention.
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 (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
- 是
入选标准
- •18 years or older
- •Signed informed consent
- •NYHA class II-III heart failure
- •EF ≤ 45% (echo within 1 year of enrollment)
- •At least 30 days of stable medical regimen (no new neurohormonal blockade or Sodium-glucose co-transporter 2 inhibitors (SGLT2i). Dose adjustments allowed)
- •Likely to be compliant with breath training as assessed by the provider
- •Availability of a "smart" phone and internet access
- •Established care at Lancaster General Health Penn Medicine
排除标准
- •Cardiac resynchronization therapy (CRT) within 6 months
- •Severe Chronic obstructive pulmonary disease (COPD)
- •History of diaphragm paralysis
- •Unable or unwilling to complete respiratory training protocol
- •Decompensated or American College of Cardiology (ACC) Stage D Heart Failure (HF)
- •Prior or planned chest/abdominal or nasal/facial surgery within 6 months
- •Neuromuscular disease which impairs respiration
- •Diagnosed cognitive impairment (unable to participate in training)
- •Untreated obstructive severe sleep apnea (AHI > 30)
- •Severe valvular heart disease
- •Uncontrolled atrial fibrillation (Ave Heart Rate (HR) > 100 bpm)
- •Orthopedic or other limitations which impair the 6-minute walk test
结局指标
主要结局
Change from baseline to 6 months for the 6-minute walk test (6MWT)
时间窗: Baseline, 6 months
Distance (m) covered in six minutes from baseline to 6 months
次要结局
- Pulmonary parameters: Peak expiratory flow(Baseline, 3 months, 6 months)
- Kansas City Cardiomyopathy Questionnaire 12 (KCCQ12) quality of life score(Baseline, 3 months, 6 months)
- New York Heart Association (NYHA) Class (graded I-IV) Proportion Improved 1 Class(Baseline, 6 months)