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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Federal University of Health Science of Porto Alegre.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Instituto de Cardiologia do Rio Grande do Sul
Information provided by:
Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier:
NCT01252407
First received: December 1, 2010
Last updated: August 1, 2012
Last verified: November 2010
  Purpose

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.


Condition Intervention
Improvement of Cardiovascular Autonomic Control
Reduction of Levels of Catecholamines
Other: transcutaneous electrical nerve stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acute Effect of Transcutaneous Electrical Nerve Stimulation on the Sympathetic and Parasympathetic Systems in Individuals With Heart Failure

Resource links provided by NLM:


Further study details as provided by Federal University of Health Science of Porto Alegre:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • improvement of heart rate variability [ Time Frame: one minute before and after transcutaneous electrical nerve stimulation intervention (acute effect) ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 30
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tens Other: transcutaneous electrical nerve stimulation
Application of low frequency (10-Hz) and high frequency (100-Hz) TENS, in two different days

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252407

Locations
Brazil
Rodrigo Della Méa Plentz
Porto Alegre, RS, Brazil
Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Instituto de Cardiologia do Rio Grande do Sul
  More Information

No publications provided

Responsible Party: Rodrigo Della Méa Plentz, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT01252407     History of Changes
Other Study ID Numbers: TensIC
Study First Received: December 1, 2010
Last Updated: August 1, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of Health Science of Porto Alegre:
Transcutaneous electrical nerve stimulation
Sympathetic nervous system
Parasympathetic nervous system
heart rate

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014