Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Functional capacity measured as peak oxygen uptake (peak VO2) in ml/min/kg .
研究概览
简要总结
Heart failure (HF) with preserved ejection fraction (HFpEF) has become the most prevalent form of HF in developed countries. Despite its increasing in prevalence, there is no evidence-based effective therapy for HFpEF The purpose of this study was to evaluate whether inspiratory muscle training (IMT), functional electrical stimulation (FES), or combination of both improve exercise capacity as well as left ventricular diastolic function, biomarkers' profile, quality of life (QoL) and prognosis in patients with HFpEF.
详细描述
This study was designed as a prospective, controlled, randomized, four-armed, efficacy trial of patients with the diagnosis of HFpEF and New York Heart Association functional class II-III/IV, diagnosed according to criteria of the European Society of Cardiology. A computer-generated randomization scheme was used to allocate participants (in a 1:1:1:1 ratio) to receive: 1) a home-based 12-week program of inspiratory muscle training (IMT) or; 2) a 12-week program of functional electrical stimulation (FES) of lower limb muscles or; 3) standard treatment (ST) alone or; 4) combination of IMT and FES. The study is being conducted in a single center in Spain. Independently of staggered entry, the minimum duration of a patient's participation is 6 months (from first to last visit). All patients will provide signed informed consent and the protocol has been approved by the research ethics committee of our center in accordance with the principles of the Declaration of Helsinki and national regulations.
Study population Candidate patients are selected from the outpatient's clinics of HF of the Hospital Clínico Universitario of Valencia.
Study objectives The primary endpoint of the study is a clinical endpoint of three and six months change in peak oxygen uptake (peak VO2).
Secondary endpoints are three and six month changes in echocardiogram parameters, QoL and prognostic biomarkers. The investigators also will specifically focus on number of episodes of worsening HF at 6 months:
- Change in E/e' after three and six months.
- Change in left atrial volume index after three and six months.
- Change in health-related QoL measured by the Minnesota Living With Heart Failure Questionnaire (MLHF) after three and six months.
- Change in natriuretic peptide (NT-proBNP) after three and six months.
- Change in minute ventilation/carbon dioxide production (VE/VCO2) slope after three and six months.
- Number of episodes of acute HF hospitalizations and number of episodes of worsening HF not requiring hospitalization at 6 months.
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
- None
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
- •Previous history of symptomatic heart failure NYHA (New York Heart Association )functional class ≥II with Normal left ventricular ejection fraction:
- •ejection fraction >0.50 by Simpson method
- •end-diastolic diameter <60 mm
- •Structural heart disease:
- •left ventricle hypertrophy/left atrial enlargement and/or
- •diastolic dysfunction estimated by 2D echocardiography
- •Previous admission for acute heart failure
- •Clinical stability, without hospital admissions in the past 3 month
排除标准
- •Perform a valid baseline exercise test
- •Significant primary moderate to severe valvular disease
- •Acute coronary syndrome or cardiac surgery within the previous three months
- •Signs of ischemia during cardiopulmonary exercise testing
- •Significant primary pulmonary disease; including pulmonary arterial hypertension, chronic thromboembolic pulmonary disease or chronic obstructive pulmonary disease
- •Any other comorbidity with an expectancy of life less than one year
结局指标
主要结局
Functional capacity measured as peak oxygen uptake (peak VO2) in ml/min/kg .
时间窗: changes at 12 weeks and 6 months
Maximal functional capacity will be evaluated with an incremental and symptom-limited cardiopulmonary exercise testing (CORTEX Metamax 3B) on a bicycle ergometer, beginning with a workload of 10 W and increasing stepwise at 10-W increments every 1 min. During exercise, patients were continuously monitored with twelve-lead electrocardiogram and blood pressure measurements every 2 min. Gas exchange data and cardiopulmonary variables were averaged every 10 seconds values. Peak VO2 is considered the highest value of VO2 during the last 20 s of exercise. The improvement \> of 10% in peak VO2 will be considered clinically meaningful
次要结局
- Functional capacity measured as distance walked in 6 minutes(changes at 12 weeks and 6 months)
- Change in echocardiographic parameter of diastolic disfunction: e' septal (cm/s)(changes in rest at 12 weeks and 6 months)
- Change in echocardiographic parameter of diastolic disfunction: left atrial volume index (mm/m2)(changes in rest at 12 weeks and 6 months)
- Change in echocardiographic parameter of diastolic disfunction: E/e' ratio(changes in rest at 12 weeks and 6 months)
- Change in health-related QoL(changes at 12 weeks and 6 months)
- Number of rehospitalizations or worsening HF at 6 months(changes at 6 months)