Clinical Value of Heart Rate Variability Indexes to Predict Outcomes After Exercise Training in Chronic Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Clinical Events
研究概览
简要总结
Controlled exercise training is a valuable therapeutic addition to pharmacological treatment in most patients with chronic heart failure, reducing long-term mortality, preventing cardiac remodeling and improving functional capacity. Despite the mechanism underlying its benefits might be multifactorial, a sustained improvement in autonomic balance is usually attributed as a major effect. Nevertheless, not all eligible subjects show the same response to exercise, probably due to several differences in the subpopulations enrolled. The investigators hypothesize that some Heart Rate Variability indexes could be valid tools to optimize the selection and follow-up of chronic heart failure patients to training
详细描述
Forty subjects followed in a University Heart Failure Management Program were prospectively included. All patients were evaluated before the randomization and after 24 weeks from enrollment. The investigators performed a detailed anamnesis and complete physical examination, Doppler echocardiography, Stress Testing, 6-minute walk test, heart rate variability analysis, and quality of life test. Patients were randomized either to a training group: performing a supervised training program, or a control group receiving usual care. All patients received an optimal pharmacologic treatment including diuretics, angiotensin converting enzyme inhibitors or angiotensin receptor blockers and beta-adrenergic blocking agents. All patients included in the training group attended a supervised program 3-days/week during 24 weeks (68-74 sessions). Physical aerobic training appears to impart beneficial changes in autonomic control of patients with chronic heart failure through both parasympathetic and sympathetic control of hear rate. These effects produce changes in several Heart Rate Variability indices as HF and rMSSD related with parasympathetic tone.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects followed in a University Heart Failure Management Program
- •maintained sinus rhythm
- •New York Heart Association Functional Class (NYHA) I to III and
- •LVEF≤40% documented by echocardiogram
- •optimal pharmacologic treatment
排除标准
- •history of stroke, myocardial infarction or extended anterior myocardial scar
- •revascularization procedures or recurrent angina within previous 3 months
- •orthopedic impairment
- •alcohol or drug abuse;
- •implant of pacemaker or cardioverter-defibrillator (AICD);
- •frequently ventricular dysrhythmias,
- •atrial flutter or fibrillation
- •insulin-dependent diabetes mellitus;
- •severe chronic obstructive pulmonary disease or renal dysfunction
- •comorbid non-cardiac disease limiting short term survival
- •previous enrollment in an ET program
- •subjects at great propensity for noncompliance
结局指标
主要结局
Clinical Events
时间窗: 6 month
Change in New York Heart Association Functional Class; Number of hospitalizations 6 months before and after the date of enrollment; temporary or permanent withdrawal from the study protocol (due to persistent atrial or ventricular arrhythmias; worsening of congestive heart failure symptoms; myocardial infarction; unstable angina; need of cardiac interventions: pacemaker, implantable cardioverter defibrillator, coronary revascularization or cardiac transplantation; stroke or transient ischemic attack; severe peripheral intermittent claudication or death observed during training or follow-up sessions
Mean heart rate
时间窗: 6 month
the mean value of the12-min Electrocardiogram-recordings was considered the resting heart rate (beats per minute)
6 minute walk test
时间窗: 6 month
walking along a 20-meter long corridor at their own pace, with the aim of covering as much ground as possible in 6 minutes. The distance walked was expressed in meter
left ventricular ejection fraction
时间窗: one year
The area-length method was measured to obtain biplane left ventricle volumes. Left Ventricle ejection fraction was derived from the standard equation (%)
quality of life
时间窗: 6 month
All the subjects completed the Short-Form 36 Health Survey (SF-36), available in its Spanish version, for measuring physical and mental quality of life
Stress Test
时间窗: 6 month
symptom limited exercise testing, measured in metabolic unit (MET)
square root of the mean squared successive differences of R-R intervals (rMSSD)
时间窗: 6 month
short-term continuous electrocardiographic recordings were performed for heart rate variability analysis. In the time domain, the square root of the mean squared successive differences of R-R intervals (rMSSD) were calculated. Units: ms
Heart rate power high-frequency (HF)
时间窗: 6 month
The high-frequency (HF), from 0.15 to 0.40 Hz of the power spectral analysis were calculated. Units: ms2/Hz
次要结局
未报告次要终点
研究者
Roberto Ricca-Mallada
Medical Doctor, Magister in Science
Universidad de la Republica