Acute Effect of Transcutaneous Electrical Nerve Stimulation in Heart Failure (TensIC)

August 1, 2012 updated by: Federal University of Health Science of Porto Alegre

Acute Effect of Transcutaneous Electrical Nerve Stimulation on the Sympathetic and Parasympathetic Systems in Individuals With Heart Failure

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil
        • Rodrigo Della Méa Plentz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tens
Other: transcutaneous electrical nerve stimulation
Application of low frequency (10-Hz) and high frequency (100-Hz) TENS, in two different days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
differences in blood levels of catecholamines differences in blood levels of catecholamines differences in blood levels of catecholamines Differences in blood levels of catecholamines
Time Frame: 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).
one minute before and after transutaneous electrical nerve stimulation intervention (acute effect)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement of heart rate variability
Time Frame: 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).
one minute before and after transcutaneous electrical nerve stimulation intervention (acute effect)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Health Science of Porto Alegre

Collaborators

Instituto de Cardiologia do Rio Grande do Sul
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

December 1, 2010

First Submitted That Met QC Criteria

December 2, 2010

First Posted (Estimate)

December 3, 2010

Study Record Updates

Last Update Posted (Estimate)

August 2, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TensIC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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