Heart Failure Clinical Trial
— REINCAOfficial title:
Clinical Value of Heart Rate Variability Indexes to Predict Outcomes After Exercise Training in Chronic Heart Failure
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
Status | Completed |
Enrollment | 40 |
Est. completion date | November 2014 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Universidad de la Republica |
Type | Measure | Description | Time frame | Safety issue |
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Primary | Clinical Events | 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 | 6 month | Yes |
Primary | Mean heart rate | the mean value of the12-min Electrocardiogram-recordings was considered the resting heart rate (beats per minute) | 6 month | Yes |
Primary | 6 minute walk test | 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 | 6 month | Yes |
Primary | left ventricular ejection fraction | The area-length method was measured to obtain biplane left ventricle volumes. Left Ventricle ejection fraction was derived from the standard equation (%) | one year | No |
Primary | quality of life | 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 | 6 month | No |
Primary | Stress Test | symptom limited exercise testing, measured in metabolic unit (MET) | 6 month | Yes |
Primary | square root of the mean squared successive differences of R-R intervals (rMSSD) | 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 | 6 month | No |
Primary | Heart rate power high-frequency (HF) | The high-frequency (HF), from 0.15 to 0.40 Hz of the power spectral analysis were calculated. Units: ms2/Hz | 6 month | No |
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