euromodulation of the vagus nerve at the auricular level and its safety, feasibility and functional assessment in patients with heart failure
- Conditions
- vagal neuromodulation, disautonomy
- Registration Number
- RBR-77wqymk
- Lead Sponsor
- niversidade Federal Fluminense
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.