Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2006-12-31
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Surgery
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.
Control
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Heart Institute (InCor) HC FMUSP
Principal Investigators
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Edimar A Bocchi, MD
Role: STUDY_CHAIR
Heart Institute (InCor) HC FMUSP
Paulo M Pego-Fernandes, MD
Role: PRINCIPAL_INVESTIGATOR
Heart Institute (InCor) HC FMUSP
Locations
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Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Countries
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References
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Conceicao-Souza GE, Pego-Fernandes PM, Cruz Fd, Guimaraes GV, Bacal F, Vieira ML, Grupi CJ, Giorgi MC, Consolim-Colombo FM, Negrao CE, Rondon MU, Moreira LF, Bocchi EA. Left cardiac sympathetic denervation for treatment of symptomatic systolic heart failure patients: a pilot study. Eur J Heart Fail. 2012 Dec;14(12):1366-73. doi: 10.1093/eurjhf/hfs132. Epub 2012 Oct 25.
Other Identifiers
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SymBlock Trial
Identifier Type: -
Identifier Source: org_study_id