Heart FailureCSB-CHFNCT02391142
Clinical Assessment of the Treatment With Cardiac Sympathetic Blockade on Chronic Heart Failure
A study testing Lidocaine in people with Heart Failure, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effect of Cardiac Sympathetic Blockade on Mortality, re-hospitalization rate, symptoms, quality of life, exercise tolerance, cardiac structure, systolic function, electrical activities and concentration of B - type natriuretic peptide precursor in patients with Chronic… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Jan 2019
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20-70 years old
- more than 3 months of chronic heart failure history or clinical symptoms of heart failure last for more than 3 months (including acute episode of chronic heart failure), chronic heart failure diagnostic criteria refer to 2012ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure
- NYHA functional class III-IV, ejection fraction ≤45%
- NT-proBNP>400ng/L
Who cannot join
- first episode of acute heart failure
- unrepaired valvular heart disease accompanied with Hemodynamic changes
- hypertrophic cardiomyopathy, pericardial disease, congenital heart disease, severe pulmonary hypertension
- Second-degree type 2 or worse sinoatrial or atrioventricular block without pacemaker therapy
- right heart failure caused by various diseases, respiratory failure or right heart failure induced by chronic obstructive pulmonary disease
- overt renal decompensation: serum creatinine>2.1mg/dl(186umol/L)
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- severe hepatic dysfunction, transaminase or alkaline phosphatase > 3 times the upper limit of normal
- Cerebral vascular accident in three months( cerebral infarction, cerebral embolism, cerebral hemorrhage,etc)
- life expectancy shorter than 6 months
- patients with a previous or present history of tumour or precancerous lesions confirmed by pathological examination
- Spine Deformity or skin infection at puncture site
- participate in any clinical drug trials in the three months
- the patients who do not sign the informed consent, unable or unwilling to comply with the requirements of the protocol or unsuitable for the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Fengqi Liu, 86-0451-85555241, fengqiliu1964@163.com
Dan Ma, 86-0451-85555240, madandoc@163.com
About this study
The purpose of this study is to evaluate the effect of Cardiac Sympathetic Blockade on Mortality, re-hospitalization rate, symptoms, quality of life, exercise tolerance, cardiac structure, systolic function, electrical activities and concentration of B - type natriuretic peptide precursor in patients with Chronic Heart Failure.
- Conditions
- Heart Failure
- Being tested
- Lidocaine
- Keywords
- heart failure, cardiac sympathetic nerve block, sympathetic nervous system
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called ropivacaine
0.5% lidocaine 5ml epidural injection every 2 hours per day or 0.2% ropivacaine 5ml epidural injection every 4 hours per day, last for 4weeks
| Study group | Role | What they receive |
|---|---|---|
| cardiac sympathetic nerve block | Experimental | lidocaine or ropivacaine epidural injection Receives: Drug: Lidocaine |
| non-cardiac sympathetic nerve block | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: one year
Secondary outcomes (1)
Rehospitalization rate
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startJun 2014
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391142
- Sponsor's protocol ID
- CSB-CHF
- Acronym
- CSB-CHF
- Status last verified
- May 2014
- First submitted
- 12 Mar 2015
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of the Treatment With Cardiac Sympathetic Blockade on Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT02391142
- Acronym / sponsor ID
- CSB-CHF / CSB-CHF
- Conditions
- Heart Failure
- Keywords
- heart failure, cardiac sympathetic nerve block, sympathetic nervous system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 18 Mar 2015 (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 purpose of this study is to evaluate the effect of Cardiac Sympathetic Blockade on Mortality, re-hospitalization rate, symptoms, quality of life, exercise tolerance, cardiac structure, systolic function, electrical activities and concentration of B - type natriuretic peptide precursor in patients with Chronic Heart Failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| cardiac sympathetic nerve block | Experimental | Drug: Lidocainelidocaine or ropivacaine epidural injection |
| non-cardiac sympathetic nerve block | No intervention | – |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 20-70 years old
- more than 3 months of chronic heart failure history or clinical symptoms of heart failure last for more than 3 months (including acute episode of chronic heart failure), chronic heart failure diagnostic criteria refer to 2012ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure
- NYHA functional class III-IV, ejection fraction ≤45%
- NT-proBNP>400ng/L
Key exclusion criteria (13 listed)
- first episode of acute heart failure
- unrepaired valvular heart disease accompanied with Hemodynamic changes
- hypertrophic cardiomyopathy, pericardial disease, congenital heart disease, severe pulmonary hypertension
- Second-degree type 2 or worse sinoatrial or atrioventricular block without pacemaker therapy
- right heart failure caused by various diseases, respiratory failure or right heart failure induced by chronic obstructive pulmonary disease
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 |
|---|---|---|
| LidocaineAlso: ropivacaine0.5% lidocaine 5ml epidural injection every 2 hours per day or 0.2% ropivacaine 5ml epidural injection every 4 hours per day, last for 4weeks | Drug | cardiac sympathetic nerve block |
Primary outcome
All cause mortality
Time frame: one year
1 secondary outcome
Rehospitalization rate
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine in people with Heart Failure, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 8 Aug 2018. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fengqi Liu, PhD (86-451-85555241, fengqiliu1964@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2018.