Improvement of Cardiovascular Autonomic ControlTensICNCT01252407
Acute Effect of Transcutaneous Electrical Nerve Stimulation in Heart Failure
A study testing transcutaneous electrical nerve stimulation in people with Improvement of Cardiovascular Autonomic Control and Reduction of Levels of Catecholamines, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Improvement of Cardiovascular Autonomic Control, Reduction of Levels of Catecholamines
- What is being tested?
- transcutaneous electrical nerve stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- transcutaneous electrical nerve stimulation
- Keywords
- Transcutaneous electrical nerve stimulation, Sympathetic nervous system, Parasympathetic nervous system, heart rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical nerve stimulationOther
Application of low frequency (10-Hz) and high frequency (100-Hz) TENS, in two different days
| Study group | Role | What they receive |
|---|---|---|
| tens | Experimental | Not described Receives: Other: transcutaneous electrical nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one minute before and after transutaneous electrical nerve stimulation intervention (acute effect)
Secondary outcomes (1)
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).
Measured: one minute before and after transcutaneous electrical nerve stimulation intervention (acute effect)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improvement of Cardiovascular Autonomic ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Instituto de Cardiologia do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252407
- Sponsor's protocol ID
- TensIC
- Acronym
- TensIC
- Status last verified
- Nov 2010
- First submitted
- 1 Dec 2010
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Transcutaneous Electrical Nerve Stimulation on the Sympathetic and Parasympathetic Systems in Individuals With Heart Failure
- ClinicalTrials.gov ID
- NCT01252407
- Acronym / sponsor ID
- TensIC / TensIC
- Keywords
- Transcutaneous electrical nerve stimulation, Sympathetic nervous system, Parasympathetic nervous system, heart rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Instituto de Cardiologia do Rio Grande do Sul
- Study start
- Nov 2010
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tens | Experimental | Other: transcutaneous electrical nerve stimulation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous electrical nerve stimulationApplication of low frequency (10-Hz) and high frequency (100-Hz) TENS, in two different days | Other | tens |
Primary outcome
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).
1 secondary outcome
improvement of heart rate variability
Time frame: one minute before and after transcutaneous electrical nerve stimulation intervention (acute effect)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical nerve stimulation in people with Improvement of Cardiovascular Autonomic Control and Reduction of Levels of Catecholamines, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: one minute before and after transutaneous electrical nerve stimulation intervention (acute effect)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2012.