A Phase 1 interventional study of Left cervico-thoracic sympathetic blockade in Systolic Heart Failure, Beta-blockers Intolerance and Beta-blockers Resistance, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-10-20.
Sponsored by University of Sao Paulo · Phase 1, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 15 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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.
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
Time frame: 30 days after operation
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)
Time frame: 6 months
This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo