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Surgical Sympathetic Blockade in Heart Failure (SymBlock)

Primary Purpose

Systolic Heart Failure, Beta-blockers Intolerance, Beta-blockers Resistance

Status

Completed

Phase

Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

Left cervico-thoracic sympathetic blockade

About this trial

This is an interventional treatment trial for Systolic Heart Failure focused on measuring Heart Failure, Sympathetic Nervous System, Sympathectomy, Adrenergic beta-Antagonists, Ventricular Dysfunction, Left

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surgery

Control

Arm Description

Outcomes

Primary Outcome Measures

Perioperative mortality and morbidity

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

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)

Full Information

NCT ID

NCT01224899

First Posted

October 18, 2010

Last Updated

October 19, 2010

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT01224899

Brief Title

Surgical Sympathetic Blockade in Heart Failure

Acronym

SymBlock

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Sao Paulo

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systolic Heart Failure, Beta-blockers Intolerance, Beta-blockers Resistance

Keywords

Heart Failure, Sympathetic Nervous System, Sympathectomy, Adrenergic beta-Antagonists, Ventricular Dysfunction, Left

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Surgery

Arm Type

Experimental

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Procedure

Intervention Name(s)

Left cervico-thoracic sympathetic blockade

Intervention Description

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

Primary Outcome Measure Information:

Title

Perioperative mortality and morbidity

Description

Time Frame

30 days after operation

Secondary Outcome Measure Information:

Title

Cardiovascular effects

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edimar A Bocchi, MD

Organizational Affiliation

Heart Institute (InCor) HC FMUSP

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Paulo M Pego-Fernandes, MD

Organizational Affiliation

Heart Institute (InCor) HC FMUSP

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

São Paulo

State/Province

ZIP/Postal Code

05403000

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

23099357

Citation

Conceicao-Souza GE, Pego-Fernandes PM, Cruz Fd, Guimaraes GV, Bacal F, Vieira ML, Grupi CJ, Giorgi MC, Consolim-Colombo FM, Negrao CE, Rondon MU, Moreira LF, Bocchi EA. Left cardiac sympathetic denervation for treatment of symptomatic systolic heart failure patients: a pilot study. Eur J Heart Fail. 2012 Dec;14(12):1366-73. doi: 10.1093/eurjhf/hfs132. Epub 2012 Oct 25.

Results Reference

derived

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