Effect of Ganglionar Electrical Stimulation on Central Arterial Pressure

University of Brasilia30 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Heart Failure Chagas Disease

Interventions

TENSDEVICE

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Ischemic and Chagas disease previously diagnosticated * Age above 40 years old Exclusion Criteria: * No vascular disease * No recent surgery * No recent infections

Locations (1)

University of Brasilia

Brasília, Federal District, Brazil

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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).

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.