Surgical Sympathetic Blockade in Heart Failure (SymBlock)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01224899
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : October 20, 2010
Information provided by:
University of Sao Paulo

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 Type : Interventional  (Clinical Trial)
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 : December 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Perioperative mortality and morbidity [ Time Frame: 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 :
  1. Cardiovascular effects [ Time Frame: 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)

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01224899

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Paulo Manuel Pego Fernandes, Heart Institute (InCor) HC FMUSP Identifier: NCT01224899     History of Changes
Other Study ID Numbers: SymBlock Trial
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: October 20, 2010
Last Verified: October 2010

Keywords provided by University of Sao Paulo:
Heart Failure
Sympathetic Nervous System
Adrenergic beta-Antagonists
Ventricular Dysfunction, Left

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases