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Clinical Value of Heart Rate Variability Indexes to Predict Outcomes After Exercise Training in Chronic Heart Failure (REINCA)

Primary Purpose

Heart Failure, Systolic Heart Failure

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cardiac Rehabilitation
Sponsored by
Universidad de la Republica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart rate variability, Systolic heart failure, Physical exercise, Parasympathetic indexes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Usual Care

    Cardiac Rehabilitation

    Arm Description

    usual care and no changes in their previous physical activity

    Exercise Training program on a 3-days/week basis during 24 weeks (68-74 sessions). Each session started with a 10-min warm-up walking period followed by 20-min of breathing exercises and free non-resistance movements of limbs. This stage was followed by pedaling during 20-minutes at a circuit resistance training protocol using a stationary cycle-ergometer. Each session ended with a cool down period (5-minutes) including diverse stretching maneuvers of engaged muscle groups. The initial bicycle-ergometer workload (WL) was defined as 50% of the maximum achieved in the previous stress testing

    Outcomes

    Primary Outcome Measures

    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
    Mean heart rate
    the mean value of the12-min Electrocardiogram-recordings was considered the resting heart rate (beats per minute)
    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
    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 (%)
    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
    Stress Test
    symptom limited exercise testing, measured in metabolic unit (MET)
    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
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    September 5, 2016
    Last Updated
    September 12, 2016
    Sponsor
    Universidad de la Republica
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02903225
    Brief Title
    Clinical Value of Heart Rate Variability Indexes to Predict Outcomes After Exercise Training in Chronic Heart Failure
    Acronym
    REINCA
    Official Title
    Clinical Value of Heart Rate Variability Indexes to Predict Outcomes After Exercise Training in Chronic Heart Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2010 (undefined)
    Primary Completion Date
    November 2013 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad de la Republica

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Systolic Heart Failure
    Keywords
    Heart rate variability, Systolic heart failure, Physical exercise, Parasympathetic indexes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    usual care and no changes in their previous physical activity
    Arm Title
    Cardiac Rehabilitation
    Arm Type
    Active Comparator
    Arm Description
    Exercise Training program on a 3-days/week basis during 24 weeks (68-74 sessions). Each session started with a 10-min warm-up walking period followed by 20-min of breathing exercises and free non-resistance movements of limbs. This stage was followed by pedaling during 20-minutes at a circuit resistance training protocol using a stationary cycle-ergometer. Each session ended with a cool down period (5-minutes) including diverse stretching maneuvers of engaged muscle groups. The initial bicycle-ergometer workload (WL) was defined as 50% of the maximum achieved in the previous stress testing
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cardiac Rehabilitation
    Other Intervention Name(s)
    Exercise training, Educational approach
    Intervention Description
    All patients included in this group attended a supervised exercise training program. A cardiologist supervised the hole training sessions. Blood pressure, pulse rate, oxygen saturation, and body weight were measured in each session. The modified Borg scale was used to measure the perceived exercise intensity
    Primary Outcome Measure Information:
    Title
    Clinical Events
    Description
    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
    Time Frame
    6 month
    Title
    Mean heart rate
    Description
    the mean value of the12-min Electrocardiogram-recordings was considered the resting heart rate (beats per minute)
    Time Frame
    6 month
    Title
    6 minute walk test
    Description
    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
    Time Frame
    6 month
    Title
    left ventricular ejection fraction
    Description
    The area-length method was measured to obtain biplane left ventricle volumes. Left Ventricle ejection fraction was derived from the standard equation (%)
    Time Frame
    one year
    Title
    quality of life
    Description
    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
    Time Frame
    6 month
    Title
    Stress Test
    Description
    symptom limited exercise testing, measured in metabolic unit (MET)
    Time Frame
    6 month
    Title
    square root of the mean squared successive differences of R-R intervals (rMSSD)
    Description
    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
    Time Frame
    6 month
    Title
    Heart rate power high-frequency (HF)
    Description
    The high-frequency (HF), from 0.15 to 0.40 Hz of the power spectral analysis were calculated. Units: ms2/Hz
    Time Frame
    6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Roberto Ricca-Mallada, MD MSc
    Organizational Affiliation
    Hospital de Clinicas
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Clinical Value of Heart Rate Variability Indexes to Predict Outcomes After Exercise Training in Chronic Heart Failure

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