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

Heart Failure Clinical Trial

— REINCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02903225
• Other study ID #: CARDIAC REHABILITATION HF
• Status: Completed
• Phase: Phase 4
• First received: September 5, 2016
• Last updated: September 12, 2016
• Start date: April 2010
• Est. completion date: November 2014

Study information

• Verified date: September 2016
• Source: Universidad de la Republica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uruguay: Comite de EticaUruguay: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic
• Systolic Heart Failure

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de la Republica

Outcome

Type	Measure	Description	Time frame	Safety issue
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