SymBlock: Surgical Sympathetic Blockade in Heart Failure

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT01224899

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Systolic Heart Failure Beta-blockers Intolerance Beta-blockers Resistance	Procedure: Left cervico-thoracic sympathetic blockade	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Surgery	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.
No Intervention: Control

Arm

Intervention/Treatment

Experimental: Surgery

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.

No Intervention: Control

Outcome Measures

Primary Outcome Measures

Perioperative mortality and morbidity [30 days after operation]
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

Secondary Outcome Measures

Cardiovascular effects [6 months]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo	SP	Brazil	05403000

Sponsors and Collaborators

University of Sao Paulo

Investigators

Study Chair: Edimar A Bocchi, MD, Heart Institute (InCor) HC FMUSP
Principal Investigator: Paulo M Pego-Fernandes, MD, Heart Institute (InCor) HC FMUSP