Surgical Sympathetic Blockade in Heart Failure

Systolic Heart Failure Clinical Trial

— SymBlock  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224899
• Other study ID #: SymBlock Trial
• Status: Completed
• Phase: Phase 1
• First received: October 18, 2010
• Last updated: October 19, 2010
• Start date: December 2006
• Est. completion date: July 2010

Study information

• Verified date: October 2010
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Research Ethics National Council - CONEP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Left cervico-thoracic sympathetic blockade
Left cervico-thoracic sympathetic blockade by videothoracoscopic clipping under general anesthesia and single-lumen orotracheal intubation in semi-sitting position.

Locations

Country	Name	City	State
Brazil	Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No