Surgical Sympathetic Blockade in Heart Failure (SymBlock)

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01224899
First received: October 18, 2010
Last updated: October 19, 2010
Last verified: October 2010
  Purpose

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 Intervention Phase
Systolic Heart Failure
Beta-blockers Intolerance
Beta-blockers Resistance
Procedure: Left cervico-thoracic sympathetic blockade
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Left Cervico-Thoracic Sympathetic Blockade by Clipping in Systolic Heart Failure: A Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Perioperative mortality and morbidity [ Time Frame: 30 days after operation ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • 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)


Enrollment: 15
Study Start Date: December 2006
Study Completion Date: July 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224899

Locations
Brazil
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
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paulo Manuel Pego Fernandes, Heart Institute (InCor) HC FMUSP
ClinicalTrials.gov Identifier: NCT01224899     History of Changes
Other Study ID Numbers: SymBlock Trial
Study First Received: October 18, 2010
Last Updated: October 19, 2010
Health Authority: Brazil: Research Ethics National Council - CONEP

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

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014