Beta-blockers Intolerance, Beta-blockers Resistance, Systolic Heart Failure
Conditions
Keywords
Heart Failure, Sympathetic Nervous System, Sympathectomy, Adrenergic beta-Antagonists, Ventricular Dysfunction, Left
Brief summary
The investigators sought to evaluate the feasibility and safety of surgical sympathetic blockade in systolic heart failure patients and secondary to assess its cardiovascular consequences.
Interventions
PROCEDURELeft cervico-thoracic sympathetic blockade
Left cervico-thoracic sympathetic blockade by videothoracoscopic clipping under general anesthesia and single-lumen orotracheal intubation in semi-sitting position.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* chronic heart failure (at least 1 month of symptoms onset) * NYHA functional class II or III * LV ejection fraction 40% or lower * resting heart rate higher than 65 bpm * either maximum beta-blocker therapy according to guidelines or no beta-blocker use for intolerance.
Exclusion criteria
* NYHA functional class I or IV * cardiogenic shock * resting heart rate ≤ 65 bpm * systolic blood pressure \< 90 mmHg * sustained ventricular tachycardia * eligibility to other surgical procedures * procedure-limiting comorbidity * presence of ICD or pacemaker * valvar, chagasic or congenital cardiomyopathy * age \> 70 years * patient refusal * contra-indication to videothoracoscopy * decompensated thyroid disease * atrial fibrillation or flutter * active infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative mortality and morbidity | 30 days after operation | Study interruption criteria: * death attributable to surgical procedure; * cardiogenic shock attributable to surgical procedure; * worsening of heart failure symptoms attributable to surgical procedure; * Horner's syndrome * hypotension or bradiarrhythmia attributable to surgical procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular effects | 6 months | * left ventricle ejection fraction (echo and gated blood pool) * end left ventricle diastolic diameter * mean heart rate * heart rate variability * New York Heart Association functional class * Minesotta Living with Heart Failure Questionnaire Score * peak oxygen consumption * walked distance in 6 minute walking test * BNP * 123-I-Metaiodobenzylguanidine (late heart/mediastinum ratio) * sympathetic peripheral nerve activity (microneurography) * baroreflex parameters (low and high frequency) |
Countries
Brazil
Outcome results
None listed