Surgical Sympathetic Blockade in Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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Left Cervico-Thoracic Sympathetic Blockade by Clipping in Systolic Heart Failure: A Randomised Controlled Trial

Conditions
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Systolic Heart Failure, Beta-blockers Intolerance, Beta-blockers Resistance

Intervention / Treatment
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* Procedure: Left cervico-thoracic sympathetic blockade


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgery<br> | Procedure: Left cervico-thoracic sympathetic blockade<br>* Left cervico-thoracic sympathetic blockade by videothoracoscopic clipping under general anesthesia and single-lumen orotracheal intubation in semi-sitting position.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative mortality and morbidity | 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 | 30 days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular effects | 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) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Sympathetic Nervous System, Sympathectomy, Adrenergic beta-Antagonists, Ventricular Dysfunction, Left