vagal neuromodulation, disautonomy
Conditions
Interventions
DESIGN: Prospective clinical study, double blind, randomized with sham methodology, single center, where patients with stable HF with an ejection fraction of less than 50% in an outpatient unit will b
E02.331.800
Sponsors
Universidade Federal Fluminense
Hospital Santa Izabel
Eligibility
Inclusion criteria
Inclusion criteria: The following will be included outpatients with compensated HF class NYHA I-II-III, receiving optimal pharmacological therapy in the last 3 months; Age over 18 years; LVEF <or equal to 50% documented by echocardiography
Exclusion criteria
Exclusion criteria: Patients with hospitalization for HF or use of intravenous CHF therapy in the past 30 days; Patients with severe severe mitral regurgitation or severe aortic stenosis; History of coronary artery disease-CAD or acute coronary syndrome in the last 3 months; Stroke or transient ischemic attack in the last 3 months; Myocardial revascularization-CABG surgery in the last 3 months; Coronary angioplasty in the last 3 months; Mitral or aortic valve replacement surgery in the last 3 months; Users or scheduled for resynchronization or pacemaker; Patients with an ejection fraction above 50%; Atrial fibrillation rhythm; In the presence of third or advanced degree of atrioventricular block
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine whether pacing is safe and feasible and demonstrate symptom reduction by measuring data from classic cardiologic exams (HRV on Holter-Ecg, Echocardiogram, Pulmonary Function Test) and measurement of quality of life (Minnesota scale ) and functional class (NYHA) and 6-minute walk test in Heart Failure. Through a comparative study of measurements found before stimulation and measurements found after 4 weeks of stimulation of the vagus-ENV nerve, at the auricular and transcutaneous levels. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate through a comparative test between the diabetic neuropathy group and the standard intervention group; if there were additional or reduced benefits in terms of symptoms, data from classic cardiologic exams (holter -ecg, echocardiogram and pulmonary function proca), quality of life and functional class in heart failure. | — |
Countries
Brazil
Contacts
Public ContactSergio Couceiro
Outcome results
None listed