This trial is active, not recruiting.

Conditions improvement of cardiovascular autonomic control, reduction of levels of catecholamines
Treatment transcutaneous electrical nerve stimulation
Sponsor Federal University of Health Science of Porto Alegre
Collaborator Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Start date November 2010
End date March 2013
Trial size 30 participants
Trial identifier NCT01252407, TensIC


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
transcutaneous electrical nerve stimulation
Application of low frequency (10-Hz) and high frequency (100-Hz) TENS, in two different days

Primary Outcomes

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)

Secondary Outcomes

improvement of heart rate variability
time frame: one minute before and after transcutaneous electrical nerve stimulation intervention (acute effect)

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Official title Acute Effect of Transcutaneous Electrical Nerve Stimulation on the Sympathetic and Parasympathetic Systems 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by Federal University of Health Science of Porto Alegre.