Heart FailureNCT01874795
Effect of Ganglionar Electrical Stimulation on Central Arterial Pressure
A study testing TENS in people with Heart Failure and Chagas Disease, run by University of Brasilia at 1 site in Brazil.
Trial summary
This study will evaluate the applications of ganglionar electrical stimulation in patients with Chagas Disease and Ischemic Heart Failure patients. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Chagas Disease
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Jun 2012
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ischemic and Chagas disease previously diagnosticated
- Age above 40 years old
Who cannot join
- No vascular disease
- No recent surgery
- No recent infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ganglionar Transcutaneous Electrical Nerve Stimulation on Central Arterial Pressure in Healthy Young Population
This study will evaluate the applications of ganglionar electrical stimulation in patients with Chagas Disease and Ischemic Heart Failure patients.
Read the detailed description
A Crossover Randomized Controlled Study will be developed with 3 groups: Healthy Older, Ischemic Heart Failure and Chagas Disease. This individuals will be randomized in two groups: TENS and placebo (same stimulus without electrical output) with 48 hrs between the interventions.
- Conditions
- Heart Failure, Chagas Disease
- Being tested
- TENS, Placebo
- Keywords
- Autonomic Nervous System, Neuromodulation, Exercise, Pulmonary oxygen kinetics, Oxygen uptake
- Medical subject headings
- Heart Failure, Chagas Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
Also called Ganglionar electrical stimulation
Adhesive electrodes (MultiStick®, USA) were placed on each side, about 3 cm to the right and left of midline vertebral process, at C7 (Channel 1) and T4 (Channel 2).
PlaceboDevice
The frequency of stimulation was 80 Hz and the pulse duration was 150 μs, equipment did not provide stimulation current.
| Study group | Role | What they receive |
|---|---|---|
| Ganglionar Electrical Stimulation | Experimental | TENS intervention consisted of continuous flow, symmetrical and rectangular TENS biphasic pulses. The frequency ofstimulation was 80 Hz and the pulse duration was 150 μs, with the intensity in adjusted to the point of muscle contraction. Receives: Device: TENS |
| Placebo | Sham comparator | The frequency of stimulation was 80 Hz and the pulse duration was 150 μs, equipment did not provide stimulation current. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
tonometry
Applanation tonometry (AT) accurately reflects arterial stiffness method and has demonstrated a strong correlation with ventricular-vascular coupling. Increased arterial stiffness and wave reflection have also been reported in patients with systolic and diastolic HF.
Measured: participants will be followed for the duration of myostimulation protocol, an expected average of 5 weeks
Secondary outcomes (1)
Cardiorespiratory Evaluation
Cardiopulmonary exercise testing (CPX) is a highly reliable and valid approach to assessing aerobic performance. It is a well-accepted assessment technique in the HF population with American and European associations endorsing its use. CPX is most often performed on a treadmill or cycle ergometer using ramping protocols and the addition of ventilatory expired gas analysis to the standard exercise test enables measurement of oxygen consumption (VO2), carbon dioxide production (VCO2) and minute ventilation (VE) over time. Moreover, CPX provides a host of variables that are predictive of adverse events in HF patients, including peak VO2, the VE/VCO2 slope and the oxygen uptake efficiency slope (OUES).
Measured: participants will be followed for the duration of myostimulation protocol, an expected average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startMar 2012
- Primary completionMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerson Cipriano Jr, University of Brasilia
- Investigators
- Gerson C junior, PhD, Principal investigator, University of BrasiliaGaspar R Chiappa, ScD, Principal investigator, University Federal of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874795
- Sponsor's protocol ID
- 071/2011
- Status last verified
- Jun 2013
- First submitted
- 11 Jul 2012
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cipriano G Jr, de Camargo Carvalho AC, Bernardelli GF, Tayar Peres PA. Short-term transcutaneous electrical nerve stimulation after cardiac surgery: effect on pain, pulmonary function and electrical muscle activity. Interact Cardiovasc Thorac Surg. 2008 Aug;7(4):539-43. doi: 10.1510/icvts.2007.168542. Epub 2008 Apr 16.
PubMed 18417519Chiappa GR, Borghi-Silva A, Ferreira LF, Carrascosa C, Oliveira CC, Maia J, Gimenes AC, Queiroga F Jr, Berton D, Ferreira EM, Nery LE, Neder JA. Kinetics of muscle deoxygenation are accelerated at the onset of heavy-intensity exercise in patients with COPD: relationship to central cardiovascular dynamics. J Appl Physiol (1985). 2008 May;104(5):1341-50. doi: 10.1152/japplphysiol.01364.2007. Epub 2008 Mar 20.
PubMed 18356477Vieira PJ, Ribeiro JP, Cipriano G Jr, Umpierre D, Cahalin LP, Moraes RS, Chiappa GR. Effect of transcutaneous electrical nerve stimulation on muscle metaboreflex in healthy young and older subjects. Eur J Appl Physiol. 2012 Apr;112(4):1327-34. doi: 10.1007/s00421-011-2084-z. Epub 2011 Jul 28.
PubMed 21796410
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ganglionar Transcutaneous Electrical Nerve Stimulation on Central Arterial Pressure in Healthy Young Population
- ClinicalTrials.gov ID
- NCT01874795
- Acronym / sponsor ID
- 071/2011
- Conditions
- Heart Failure, Chagas Disease
- Keywords
- Autonomic Nervous System, Neuromodulation, Exercise, Pulmonary oxygen kinetics, Oxygen uptake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 11 Jun 2013 (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.
This study will evaluate the applications of ganglionar electrical stimulation in patients with Chagas Disease and Ischemic Heart Failure patients.
Detailed description
A Crossover Randomized Controlled Study will be developed with 3 groups: Healthy Older, Ischemic Heart Failure and Chagas Disease. This individuals will be randomized in two groups: TENS and placebo (same stimulus without electrical output) with 48 hrs between the interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ganglionar Electrical Stimulation | Experimental | Device: TENSTENS intervention consisted of continuous flow, symmetrical and rectangular TENS biphasic pulses. The frequency ofstimulation was 80 Hz and the pulse duration was 150 μs, with the intensity in adjusted to the point of muscle contraction. |
| Placebo | Sham comparator | Device: PlaceboThe frequency of stimulation was 80 Hz and the pulse duration was 150 μs, equipment did not provide stimulation current. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ischemic and Chagas disease previously diagnosticated
- Age above 40 years old
Key exclusion criteria (3 listed)
- No vascular disease
- No recent surgery
- No recent infections
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 |
|---|---|---|
| TENSAlso: Ganglionar electrical stimulationAdhesive electrodes (MultiStick®, USA) were placed on each side, about 3 cm to the right and left of midline vertebral process, at C7 (Channel 1) and T4 (Channel 2). | Device | Ganglionar Electrical Stimulation |
| PlaceboThe frequency of stimulation was 80 Hz and the pulse duration was 150 μs, equipment did not provide stimulation current. | Device | Placebo |
Primary outcome
tonometry
Time frame: participants will be followed for the duration of myostimulation protocol, an expected average of 5 weeks
Applanation tonometry (AT) accurately reflects arterial stiffness method and has demonstrated a strong correlation with ventricular-vascular coupling. Increased arterial stiffness and wave reflection have also been reported in patients with systolic and diastolic HF.
1 secondary outcome
Cardiorespiratory Evaluation
Time frame: participants will be followed for the duration of myostimulation protocol, an expected average of 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
- Background: PubMed 18417519Cipriano G Jr, de Camargo Carvalho AC, Bernardelli GF, Tayar Peres PA. Short-term transcutaneous electrical nerve stimulation after cardiac surgery: effect on pain, pulmonary function and electrical muscle activity. Interact Cardiovasc Thorac Surg. 2008 Aug;7(4):539-43. doi: 10.1510/icvts.2007.168542. Epub 2008 Apr 16.
- Background: PubMed 18356477Chiappa GR, Borghi-Silva A, Ferreira LF, Carrascosa C, Oliveira CC, Maia J, Gimenes AC, Queiroga F Jr, Berton D, Ferreira EM, Nery LE, Neder JA. Kinetics of muscle deoxygenation are accelerated at the onset of heavy-intensity exercise in patients with COPD: relationship to central cardiovascular dynamics. J Appl Physiol (1985). 2008 May;104(5):1341-50. doi: 10.1152/japplphysiol.01364.2007. Epub 2008 Mar 20.
- Background: PubMed 21796410Vieira PJ, Ribeiro JP, Cipriano G Jr, Umpierre D, Cahalin LP, Moraes RS, Chiappa GR. Effect of transcutaneous electrical nerve stimulation on muscle metaboreflex in healthy young and older subjects. Eur J Appl Physiol. 2012 Apr;112(4):1327-34. doi: 10.1007/s00421-011-2084-z. Epub 2011 Jul 28.
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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.
Gerson C junior, PhD principal investigator
University of Brasilia
Gaspar R Chiappa, ScD principal investigator
University Federal of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Heart Failure and Chagas Disease, run by University of Brasilia 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 11 Jun 2013. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
tonometry (time frame: participants will be followed for the duration of myostimulation protocol, an expected average of 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01874795, which also lists 3 linked publications.
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 11 Jun 2013.