Status:
COMPLETED
Surgical Sympathetic Blockade in Heart Failure
Lead Sponsor:
University of Sao Paulo
Conditions:
Systolic Heart Failure
Beta-blockers Intolerance
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01224899
Start Date
December 1 2006
End Date
July 1 2010
Last Update
October 20 2010
Active Locations (1)
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1
Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil, 05403000