Skip to content

Acute Effect of Transcutaneous Electrical Nerve Stimulation in Heart Failure

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01252407
Acronym
TensIC
Enrollment
30
Registered
2010-12-03
Start date
2010-11-30
Completion date
2013-12-31
Last updated
2012-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improvement of Cardiovascular Autonomic Control, Reduction of Levels of Catecholamines

Keywords

Transcutaneous electrical nerve stimulation, Sympathetic nervous system, Parasympathetic nervous system, heart rate

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.

Interventions

OTHERtranscutaneous electrical nerve stimulation

Application of low frequency (10-Hz) and high frequency (100-Hz) TENS, in two different days

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
CollaboratorOTHER_GOV
Instituto de Cardiologia do Rio Grande do Sul
CollaboratorOTHER
Federal University of Health Science of Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
differences in blood levels of catecholamines differences in blood levels of catecholamines differences in blood levels of catecholamines Differences in blood levels of catecholaminesone 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).

Secondary

MeasureTime frameDescription
improvement of heart rate variabilityone 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).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026