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Completed

NCT Number: NCT01224899

Surgical Sympathetic Blockade in Heart Failure

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.

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Key information

Conditions

Systolic Heart Failure Beta-blockers Intolerance Beta-blockers Resistance Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure, Systolic Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Left cervico-thoracic sympathetic blockade

Procedure

Left cervico-thoracic sympathetic blockade by videothoracoscopic clipping under general anesthesia and single-lumen orotracheal intubation in semi-sitting position.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Acronym: SymBlock

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Oct 20, 2010
Registry last updated
Oct 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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