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

NCT02903225 | Completed Phase 4

• 1 other identifier: CARDIAC REHABILITATION HF
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Conditions

Heart Failure; Systolic Heart Failure

Keywords

Heart rate variability; Systolic heart failure; Physical exercise; Parasympathetic indexes

Outcome Measures

Primary Outcomes (8)

• 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

• Mean heart rate

  the mean value of the12-min Electrocardiogram-recordings was considered the resting heart rate (beats per minute)

  6 month

• 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

• 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

• 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

• Stress Test

  symptom limited exercise testing, measured in metabolic unit (MET)

  6 month

• 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

• 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

Study Arms (2)

Usual Care

NO INTERVENTION

usual care and no changes in their previous physical activity

Cardiac Rehabilitation

ACTIVE COMPARATOR

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

Behavioral: Cardiac Rehabilitation

Interventions

Cardiac Rehabilitation BEHAVIORAL

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

Also known as: Exercise training, Educational approach

Cardiac Rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de la Republica: lead

MeSH Terms

Conditions

Heart Failure; Heart Failure, Systolic; Motor Activity

Interventions

Cardiac Rehabilitation; Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Roberto Ricca-Mallada, MD MSc

  Hospital de Clinicas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Magister in Science

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: September 16, 2016
• Study Start: April 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2014
• Last Updated: September 16, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share