Surgical Sympathetic Blockade in Heart Failure

NCT ID: NCT01224899

Last Updated: 2010-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systolic Heart Failure Beta-blockers Intolerance Beta-blockers Resistance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Surgery

Group Type EXPERIMENTAL

Left cervico-thoracic sympathetic blockade

Intervention Type PROCEDURE

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

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Heart Institute (InCor) HC FMUSP

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Edimar A Bocchi, MD

Role: STUDY_CHAIR

Heart Institute (InCor) HC FMUSP

Paulo M Pego-Fernandes, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute (InCor) HC FMUSP

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

São Paulo, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 23099357 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SymBlock Trial

Identifier Type: -

Identifier Source: org_study_id