Acute Effect of Transcutaneous Electrical Nerve Stimulation in Heart Failure

Improvement of Cardiovascular Autonomic Control Clinical Trial

— TensIC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01252407
• Other study ID #: TensIC
• Status: Active, not recruiting
• Phase: N/A
• First received: December 1, 2010
• Last updated: August 1, 2012
• Start date: November 2010
• Est. completion date: December 2013

Study information

• Verified date: November 2010
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Improvement of Cardiovascular Autonomic Control
• Reduction of Levels of Catecholamines

Intervention

Other:
• transcutaneous electrical nerve stimulation
Application of low frequency (10-Hz) and high frequency (100-Hz) TENS, in two different days

Locations

Country	Name	City	State
Brazil	Rodrigo Della Méa Plentz	Porto Alegre	RS

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	differences in blood levels of catecholamines differences in blood levels of catecholamines differences in blood levels of catecholamines Differences in blood levels of catecholamines	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)	No
Secondary	improvement of heart rate variability	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)	No