Clinical trial NCT01252407: Acute Effect of Transcutaneous Electrical Nerve Stimulation in Heart Failure
Official title: Acute Effect of Transcutaneous Electrical Nerve Stimulation on the Sympathetic and Parasympathetic Systems in Individuals With Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Improvement of Cardiovascular Autonomic Control
Reduction of Levels of Catecholamines
Keywords: Transcutaneous electrical nerve stimulation
Sympathetic nervous system
Parasympathetic nervous system
heart rate
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Instituto de Cardiologia do Rio Grande do Sul
First posted: 2010-12-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: differences in blood levels of catecholamines differences in blood levels of catecholamines differences in blood levels of catecholamines Differences in blood levels of catecholamines
timeFrame: one minute before and after transutaneous electrical nerve stimulation intervention (acute effect)
Secondary outcomes:
measure: improvement of heart rate variability
timeFrame: one minute before and after transcutaneous electrical nerve stimulation intervention (acute effect)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Rodrigo Della Méa Plentz
state: RS
Study officials:
References: