Surgical Sympathetic Blockade in Heart Failure

Phase 1

Completed

• Conditions: Systolic Heart Failure; Beta-blockers Intolerance; Beta-blockers Resistance
• Interventions: Procedure: Left cervico-thoracic sympathetic blockade

• Registration Number: NCT01224899
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2009-11
• Study Completion: 2010-07
• Status Verified: 2010-10
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-19
• Last Update Submitted: 2010-10-19
• Study First Posted: 2010-10-20
• Last Update Posted: 2010-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery	Left cervico-thoracic sympathetic blockade	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo; 🇧🇷 São Paulo, SP, Brazil