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Completed

NCT Number: NCT01874795

Effect of Ganglionar Electrical Stimulation on Central Arterial Pressure

This study will evaluate the applications of ganglionar electrical stimulation in patients with Chagas Disease and Ischemic Heart Failure patients.

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Key information

Conditions

Heart Failure Behavior Cardiovascular Diseases Chagas Disease Euglenozoa Infections Heart Diseases Infections Motor Activity Parasitic Diseases Protozoan Infections Trypanosomiasis Vector Borne Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Brasilia

Brasília, Federal District, 700000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

TENS

Device

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).

Other names: Ganglionar electrical stimulation

PLACEBO

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Cardiorespiratory Evaluation

    Time frame: participants will be followed for the duration of myostimulation protocol, an expected average of 5 weeks

    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).

Sponsors and collaborators

Lead sponsor

University of Brasilia

Other

Registry information

Official study title

Effect of Ganglionar Transcutaneous Electrical Nerve Stimulation on Central Arterial Pressure in Healthy Young Population

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 11, 2013
Registry last updated
Jun 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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