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Acute Effect of Transcutaneous Electrical Nerve Stimulation in Heart Failure

NCT ID: NCT01252407

Last Updated: 2012-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Improvement of Cardiovascular Autonomic Control Reduction of Levels of Catecholamines

Keywords

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Transcutaneous electrical nerve stimulation Sympathetic nervous system Parasympathetic nervous system heart rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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tens

Group Type EXPERIMENTAL

transcutaneous electrical nerve stimulation

Intervention Type OTHER

Application of low frequency (10-Hz) and high frequency (100-Hz) TENS, in two different days

Interventions

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transcutaneous electrical nerve stimulation

Application of low frequency (10-Hz) and high frequency (100-Hz) TENS, in two different days

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Instituto de Cardiologia do Rio Grande do Sul

OTHER

Sponsor Role collaborator

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Federal University of Health Science of Porto Alegre

Locations

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Rodrigo Della Méa Plentz

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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TensIC

Identifier Type: -

Identifier Source: org_study_id