Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02903225
Other study ID # CARDIAC REHABILITATION HF
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
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