Surgical Sympathetic Blockade in Heart Failure (SymBlock)

University of Sao Paulo

Status and phase: Completed; Phase 1

Conditions: Systolic Heart Failure; Beta-blockers Intolerance; Beta-blockers Resistance

Treatments: Procedure: Left cervico-thoracic sympathetic blockade

Study type: Interventional

Funder types: Other

Identifiers

NCT01224899

SymBlock Trial

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Surgery

Experimental group

Treatment:

Procedure: Left cervico-thoracic sympathetic blockade

Control

No Intervention group