Acute Effect of Transcutaneous Electrical Nerve Stimulation in Heart Failure (TensIC)
August 1, 2012 updated by: Federal University of Health Science of Porto Alegre
Acute Effect of Transcutaneous Electrical Nerve Stimulation on the Sympathetic and Parasympathetic Systems in Individuals With Heart Failure
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.
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil
- Rodrigo Della Méa Plentz
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: tens
|
Application of low frequency (10-Hz) and high frequency (100-Hz) TENS, in two different days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
improvement of heart rate variability
Time Frame: one 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).
|
one minute before and after transcutaneous electrical nerve stimulation intervention (acute effect)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Anticipated)
March 1, 2013
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
December 1, 2010
First Submitted That Met QC Criteria
December 2, 2010
First Posted (Estimate)
December 3, 2010
Study Record Updates
Last Update Posted (Estimate)
August 2, 2012
Last Update Submitted That Met QC Criteria
August 1, 2012
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TensIC
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