Systolic Heart FailurePhase 1SymBlockNCT01224899
Surgical Sympathetic Blockade in Heart Failure
A Phase 1 study testing Left cervico-thoracic sympathetic blockade in people with Systolic Heart Failure and Beta-blockers Intolerance, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systolic Heart Failure, Beta-blockers Intolerance, Beta-blockers Resistance
- What is being tested?
- Left cervico-thoracic sympathetic blockade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2006to Jul 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403000
About this study
Official title: Left Cervico-Thoracic Sympathetic Blockade by Clipping in Systolic Heart Failure: A Randomised Controlled Trial
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.
- Being tested
- Left cervico-thoracic sympathetic blockade
- Keywords
- Heart Failure, Sympathetic Nervous System, Sympathectomy, Adrenergic beta-Antagonists, Ventricular Dysfunction, Left
- Medical subject headings
- Heart Failure, Systolic, Heart Failure, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left cervico-thoracic sympathetic blockadeProcedure or surgery
Left cervico-thoracic sympathetic blockade by videothoracoscopic clipping under general anesthesia and single-lumen orotracheal intubation in semi-sitting position.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Not described Receives: Procedure: Left cervico-thoracic sympathetic blockade |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days after operation
Secondary outcomes (1)
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startDec 2006
- Primary completionNov 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systolic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Edimar A Bocchi, MD, Study chair, Heart Institute (InCor) HC FMUSPPaulo M Pego-Fernandes, MD, Principal investigator, Heart Institute (InCor) HC FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224899
- Sponsor's protocol ID
- SymBlock Trial
- Acronym
- SymBlock
- Status last verified
- Oct 2010
- First submitted
- 18 Oct 2010
- Last updated
- 20 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23099357
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Cervico-Thoracic Sympathetic Blockade by Clipping in Systolic Heart Failure: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01224899
- Acronym / sponsor ID
- SymBlock / SymBlock Trial
- Keywords
- Heart Failure, Sympathetic Nervous System, Sympathectomy, Adrenergic beta-Antagonists, Ventricular Dysfunction, Left
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: Left cervico-thoracic sympathetic blockade |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- NYHA functional class I or IV
- cardiogenic shock
- resting heart rate ≤ 65 bpm
- systolic blood pressure < 90 mmHg
- sustained ventricular tachycardia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left cervico-thoracic sympathetic blockadeLeft cervico-thoracic sympathetic blockade by videothoracoscopic clipping under general anesthesia and single-lumen orotracheal intubation in semi-sitting position. | Procedure or surgery | Surgery |
Primary outcome
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
1 secondary outcome
Cardiovascular effects
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2010.
- Derived from this study: PubMed 23099357Conceicao-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edimar A Bocchi, MD study chair
Heart Institute (InCor) HC FMUSP
Paulo M Pego-Fernandes, MD principal investigator
Heart Institute (InCor) HC FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Left cervico-thoracic sympathetic blockade in people with Systolic Heart Failure and Beta-blockers Intolerance, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative mortality and morbidity (time frame: 30 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01224899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2010; AzTrials last refreshed its copy on 31 Oct 2026.