Clinical Value of Heart Rate Variability Indexes to Predict Outcomes After

Status Completed

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

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02903225
Study type	Interventional
Source	Universidad de la Republica
Contact
Status	Completed
Phase	Phase 4
Start date	April 2010
Completion date	November 2014

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05654272` - Development of CIRC Technologies
Recruiting	`NCT05196659` - Collaborative Quality Improvement (C-QIP) Study	N/A
Recruiting	`NCT05650307` - CV Imaging of Metabolic Interventions
Active, not recruiting	`NCT05896904` - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction	N/A
Completed	`NCT05077293` - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting	`NCT05631275` - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation	`NCT05564572` - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology	N/A
Enrolling by invitation	`NCT05009706` - Self-care in Older Frail Persons With Heart Failure Intervention	N/A
Recruiting	`NCT04177199` - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated	`NCT03615469` - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)	N/A
Recruiting	`NCT06340048` - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure	Phase 1/Phase 2
Recruiting	`NCT05679713` - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed	`NCT04254328` - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure	N/A
Completed	`NCT03549169` - Decision Making for the Management the Symptoms in Adults of Heart Failure	N/A
Recruiting	`NCT05572814` - Transform: Teaching, Technology, and Teams	N/A
Enrolling by invitation	`NCT05538611` - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting	`NCT04262830` - Cancer Therapy Effects on the Heart
Completed	`NCT06026683` - Conduction System Stimulation to Avoid Left Ventricle Dysfunction	N/A
Withdrawn	`NCT03091998` - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support	Phase 1
Recruiting	`NCT05564689` - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms