Chagas Disease, Heart Failure
Conditions
Keywords
Autonomic Nervous System, Neuromodulation, Exercise, Pulmonary oxygen kinetics, Oxygen uptake
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.
Interventions
DEVICETENS
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).
DEVICEPlacebo
The frequency of stimulation was 80 Hz and the pulse duration was 150 μs, equipment did not provide stimulation current.
Sponsors
University of Brasilia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Ischemic and Chagas disease previously diagnosticated * Age above 40 years old
Exclusion criteria
* No vascular disease * No recent surgery * No recent infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tonometry | 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
| Measure | Time frame | Description |
|---|---|---|
| Cardiorespiratory Evaluation | 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). |
Countries
Brazil
Outcome results
None listed