Acute Effect of Transcutaneous Electrical Nerve Stimulation in Heart Failure

Not Applicable

• Conditions: Reduction of Levels of Catecholamines; Improvement of Cardiovascular Autonomic Control
• Interventions: Other: transcutaneous electrical nerve stimulation

• Registration Number: NCT01252407
• Lead Sponsor: Federal University of Health Science of Porto Alegre

Brief Summary

The purpose of this study is to determine acute effect the transctutaneous electrical nerve stimulation in sympathetic and parassympathetic system in individuals with heart failure.

Detailed Description

Heart failure (HF) is the inability of the heart to maintain adequate levels of blood supply to tissues. In recent years there has been an increased prevalence of heart failure (HF), in Brazil there are about two million people diagnosed with HF and 240,000 new cases per year. Thus, the IC constitutes the most serious problem now and in the fields of cardiology and public health. Sympathetic activity is increased and correlates with a worse prognosis and survival in these patients. Currently, the pharmacological blockade of the sympathetic system by chronic use of beta-blockers are commonly used to treat hyperactivity, but these interventions have side effects. The transcutaneous electrical nerve stimulation (TENS) has been used successfully to control pain in different clinical conditions and may be a noninvasive strategy to reduce drug and not the severity of increased sympathetic.

Study Timeline

• Status Verified: 2010-11
• Study Start: 2010-11
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-02
• Study First Posted: 2010-12-03
• Last Update Submitted: 2012-08-01
• Last Update Posted: 2012-08-02
• Primary Completion: 2013-03
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Possess stable heart failure grade II or III according to NYHA;
• Ejection fraction <40% determined by echocardiography;
• Having no change in drug therapy one month before being included in the study;
• There have been Myocardial Infarction (AMI) three months before study entry;

Exclusion Criteria

• Patients with grade IV heart failure according to NYHA;
• Acute respiratory;
• Unstable angina;
• Ventricular arrhythmia, unstable until three months before the start of the study;
• Pacemaker;
• Active smoking;
• Diabetes mellitus;
• And fever or infectious disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tens	transcutaneous electrical nerve stimulation	-

Primary Outcome Measures

Name	Time	Method
differences in blood levels of catecholamines differences in blood levels of catecholamines differences in blood levels of catecholamines Differences in blood levels of catecholamines	one minute before and after transutaneous electrical nerve stimulation intervention (acute effect)	For evaluation of catecholamines (epinephrine, norepinephrine and dopamine) will be held one antecubital venipuncture and collected into tubes containing ethylenediaminetetraacetic acid (EDTA).

Secondary Outcome Measures

Name	Time	Method
improvement of heart rate variability	one minute before and after transcutaneous electrical nerve stimulation intervention (acute effect)	Temporal series of the tachogram, related to each selected segment were evaluated quantitatively considering the values of HR, total and normalized powers of low frequency (LF - 0.04 to 0.15 Hz) and high frequency (HF - 0.15 to 0.40 Hz) components of HRV and the sympato-vagal index (LF/HF).

Trial Locations

Locations (1)

Rodrigo Della Méa Plentz; 🇧🇷 Porto Alegre, RS, Brazil