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Effect of Ganglionar Electrical Stimulation on Central Arterial Pressure

Primary Purpose

Heart Failure, Chagas Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
TENS
Placebo
Sponsored by
University of Brasilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Autonomic Nervous System, Neuromodulation, Exercise, Pulmonary oxygen kinetics, Oxygen uptake

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Ischemic and Chagas disease previously diagnosticated
  • Age above 40 years old

Exclusion Criteria:

  • No vascular disease
  • No recent surgery
  • No recent infections

Sites / Locations

  • University of Brasilia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ganglionar Electrical Stimulation

Placebo

Arm Description

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.

The frequency of stimulation was 80 Hz and the pulse duration was 150 μs, equipment did not provide stimulation current.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
July 11, 2012
Last Updated
June 6, 2013
Sponsor
University of Brasilia
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1. Study Identification

Unique Protocol Identification Number
NCT01874795
Brief Title
Effect of Ganglionar Electrical Stimulation on Central Arterial Pressure
Official Title
Effect of Ganglionar Transcutaneous Electrical Nerve Stimulation on Central Arterial Pressure in Healthy Young Population
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Brasilia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Chagas Disease
Keywords
Autonomic Nervous System, Neuromodulation, Exercise, Pulmonary oxygen kinetics, Oxygen uptake

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ganglionar Electrical Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
The frequency of stimulation was 80 Hz and the pulse duration was 150 μs, equipment did not provide stimulation current.
Intervention Type
Device
Intervention Name(s)
TENS
Other Intervention Name(s)
Ganglionar electrical stimulation
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
The frequency of stimulation was 80 Hz and the pulse duration was 150 μs, equipment did not provide stimulation current.
Primary Outcome Measure Information:
Title
tonometry
Description
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.
Time Frame
participants will be followed for the duration of myostimulation protocol, an expected average of 5 weeks
Secondary Outcome Measure Information:
Title
Cardiorespiratory Evaluation
Description
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).
Time Frame
participants will be followed for the duration of myostimulation protocol, an expected average of 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ischemic and Chagas disease previously diagnosticated Age above 40 years old Exclusion Criteria: No vascular disease No recent surgery No recent infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerson C junior, PhD
Organizational Affiliation
University of Brasilia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gaspar R Chiappa, ScD
Organizational Affiliation
University Federal of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Brasilia
City
Brasilia
State/Province
DF
ZIP/Postal Code
700000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
18417519
Citation
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.
Results Reference
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PubMed Identifier
18356477
Citation
Chiappa 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.
Results Reference
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PubMed Identifier
21796410
Citation
Vieira 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.
Results Reference
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Effect of Ganglionar Electrical Stimulation on Central Arterial Pressure

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