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

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ClinicalTrials.gov Identifier: NCT02903225
Recruitment Status : Completed
First Posted : September 16, 2016
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
Roberto Ricca-Mallada, Universidad de la Republica

Tracking Information
First Submitted Date  ICMJE September 5, 2016
First Posted Date  ICMJE September 16, 2016
Last Update Posted Date September 16, 2016
Study Start Date  ICMJE April 2010
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2016)
  • Clinical Events [ Time Frame: 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 [ Time Frame: 6 month ]
    the mean value of the12-min Electrocardiogram-recordings was considered the resting heart rate (beats per minute)
  • 6 minute walk test [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 month ]
    symptom limited exercise testing, measured in metabolic unit (MET)
  • square root of the mean squared successive differences of R-R intervals (rMSSD) [ Time Frame: 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) [ Time Frame: 6 month ]
    The high-frequency (HF), from 0.15 to 0.40 Hz of the power spectral analysis were calculated. Units: ms2/Hz
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Value of Heart Rate Variability Indexes to Predict Outcomes After Exercise Training in Chronic Heart Failure
Official Title  ICMJE Clinical Value of Heart Rate Variability Indexes to Predict Outcomes After Exercise Training in Chronic Heart Failure
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure
  • Systolic Heart Failure
Intervention  ICMJE Behavioral: Cardiac Rehabilitation
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
Other Names:
  • Exercise training
  • Educational approach
Study Arms  ICMJE
  • No Intervention: Usual Care
    usual care and no changes in their previous physical activity
  • Active Comparator: Cardiac Rehabilitation
    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: Behavioral: Cardiac Rehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2016)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02903225
Other Study ID Numbers  ICMJE CARDIAC REHABILITATION HF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Roberto Ricca-Mallada, Universidad de la Republica
Study Sponsor  ICMJE Universidad de la Republica
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roberto Ricca-Mallada, MD MSc Hospital de Clinicas
PRS Account Universidad de la Republica
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP