Acute Effect of Transcutaneous Electrical Nerve Stimulation in Heart Failure (TensIC)
Primary Purpose
Improvement of Cardiovascular Autonomic Control, Reduction of Levels of Catecholamines
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
transcutaneous electrical nerve stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Improvement of Cardiovascular Autonomic Control focused on measuring Transcutaneous electrical nerve stimulation, Sympathetic nervous system, Parasympathetic nervous system, heart rate
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.
Sites / Locations
- Rodrigo Della Méa Plentz
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
tens
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT01252407
First Posted
December 1, 2010
Last Updated
August 1, 2012
Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Instituto de Cardiologia do Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT01252407
Brief Title
Acute Effect of Transcutaneous Electrical Nerve Stimulation in Heart Failure
Acronym
TensIC
Official Title
Acute Effect of Transcutaneous Electrical Nerve Stimulation on the Sympathetic and Parasympathetic Systems in Individuals With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Instituto de Cardiologia do Rio Grande do Sul
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Improvement of Cardiovascular Autonomic Control, Reduction of Levels of Catecholamines
Keywords
Transcutaneous electrical nerve stimulation, Sympathetic nervous system, Parasympathetic nervous system, heart rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tens
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
transcutaneous electrical nerve stimulation
Intervention Description
Application of low frequency (10-Hz) and high frequency (100-Hz) TENS, in two different days
Primary Outcome Measure Information:
Title
differences in blood levels of catecholamines differences in blood levels of catecholamines differences in blood levels of catecholamines Differences in blood levels of catecholamines
Description
For evaluation of catecholamines (epinephrine, norepinephrine and dopamine) will be held one antecubital venipuncture and collected into tubes containing ethylenediaminetetraacetic acid (EDTA).
Time Frame
one minute before and after transutaneous electrical nerve stimulation intervention (acute effect)
Secondary Outcome Measure Information:
Title
improvement of heart rate variability
Description
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).
Time Frame
one minute before and after transcutaneous electrical nerve stimulation intervention (acute effect)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Rodrigo Della Méa Plentz
City
Porto Alegre
State/Province
RS
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Acute Effect of Transcutaneous Electrical Nerve Stimulation in Heart Failure
We'll reach out to this number within 24 hrs