Chronic Heart FailureRSD4CHFNCT01790906
Renal Sympathetic Denervation for Patients With Chronic Heart Failure
A study testing RSD and Conventional therapy in people with Chronic Heart Failure, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
To study whether renal sympathetic denervation(RSD) RSD can slow the progression of CHF and reduce the rate of all-cause mortality effectively and securely. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- RSD and Conventional therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Apr 2017
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individual is ≥18 and ≤ 75 years of age
- Individual has a history of heart failure more than half a year
- Individual's Cardiac function is betweenⅡ-Ⅳlevel(NYHA)
- Ejection fraction ≦ 35%
- Renal artery CTA (computed tomographic arteriography)inspection renal artery length ≧ 2 cm, diameter ≧ 4 mm, no single double renal artery, renal artery start without distortion/tumor sample expansion,ect
- Individual agrees to have all study procedures performed and is competent and willing to provide written,informed consent to participate in this clinical study
Who cannot join
- Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
- Individual has experienced renal artery stenosis,or A history of prior renal artery intervention including balloon angioplasty or stenting.
- Individual has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2, using the MDRD(Modification of Diet in Renal Disease) calculation.
- Individual has Acute heart failure.
- Individual has experienced a cerebrovascular accident within 3 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
- Individual has experienced sick sinus syndrome.
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- Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia, or arrhythmias such as atrial fibrillation).
- Individual is pregnant, nursing or planning to be pregnant. [Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to treatment.]
- Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
- Individual is currently enrolled in another investigational drug or device trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Nanjing Meddical University
Nanjing, Jiangsu, 210000
Qijun Shan, Professor, 02568136407, qjshan@njmu.edu.cn
Qijun Shan, Professor
About this study
Official title: Safety and Effectiveness Study of Percutaneous Catheter-base Renal Sympathetic Denervation for Patients With Chronic Heart Failure
To study whether renal sympathetic denervation(RSD) RSD can slow the progression of CHF and reduce the rate of all-cause mortality effectively and securely.
Read the detailed description
Chronic heart failure(CHF) as the final stage of various heart diseases is a global and growing public health problem, and its morbidity increases with age. At present, the main therapies for CHF contain drug therapy (including angiotensin-converting enzyme inhibitors, aldosterone antagonist, beta-receptor blockers, diuretic, digoxin etc ) , CRT-D(cardiac resynchronization therapy )/ICD(implantable cardioverter-defibrillator), biological treatment, ultrafiltration dialysis, heart transplantation and so on. Optimize drug therapy is the foundation of CHF, but hypotension and bradycardia limit its indications. ESC(European Society of Cardiology)/AHA(American Heart Association) guidelines recommended CRT-P/D and ICD for drug resistant CHF, but the financial burden limit the use of them and some patients have no response to them. Donors and high costs are considered as two problems which limit heart transplantation appeal. Above all, we are always searching for a new treatment strategy for patients with chronic heart failure. Chronic over-activation of sympathetic nervous system is a major component of heart failure and involves efferent and afferent pathways between brain and many organs. Recently, some studies in animals and humans suggest that activation of both efferent and afferent renal nerves play a crucial role in the pathogenesis and progression of CHF. Activation of renal nerves in CHF may cause a reflex increase in sympathetic tone that contributes to elevated peripheral vascular resistance and vascular remodeling as well as left ventricular remodeling and dysfunction. Recently, many clinical trials have corroborated that catheter-based renal sympathetic denervation (RSD) significantly decreased sympathetic-nerve activity (MSNA) in muscle and whole-body, with a decrease in renal and whole-body norepinephrine spillover. Simultaneously, many clinical researches have also verified that RSD can safely be used to control hypertension, reduce left ventricular hypertrophy, improve glucose tolerance impaired ,decrease proteinuria and sleep apnea severity, which are all recognized as independent risk factors for the development and progression of CHF. Therefore, this randomized parallel control clinical trial was designed to demonstrate whether RSD can slow the progression of CHF and reduce the rate of all-cause mortality effectively and securely.
- Conditions
- Chronic Heart Failure
- Being tested
- RSD, Conventional therapy
- Keywords
- Chronic Heart Failure, Renal Sympathetic Denervation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSDProcedure or surgery
Also called renal sympathetic denervation, renal denervation, renal ablation
Contrast renal angiography was performed to localize and assess the renal arteries for accessibility and appropriateness for RSD .once the anatomy was deemed acceptable, the internally irrigated radiofrequency ablation catheter(Celsius Thermocool,Biosense Webster,Diamond Bar,California)was introduced into each renal artery.then was maneuvered within the renal artery to allow energy delivery in a circumferential,longitudinally staggered manner to minimize the chance of renal artery stenosis.About six to nine ablation at 10W for 1 min each were performed in both renal arteries.during ablation, the catheter system monitored tip temperature and impedance,altering radiofrequency energy delivery in response to predetermined algorithm.
Conventional therapyOther
Optimizing drug therapy,included angiotensin-converting enzyme inhibitors,aldosterone antagonist,beta-receptor blockers,diuretic,digoxin and so on.The patients with chronic heart failure ,whos'condition need for CRT-D(cardiac resynchronization therapy )/ICD(implantable cardioverter-defibrillator),are considered to implant CRT/ICD .CRT is abbreviation for cardiac resynchronization therapy ,ICD is defined for Implantable Cardioverter defibrillator.
| Study group | Role | What they receive |
|---|---|---|
| RSD+Conventional therapy | Active comparator | We will recruit 100 randomised CHF patients who meet the inclusion criteria.First undergo renal artery angiography procedure to confirm anatomy.If renal artery meet the inclusion criteria,give the renal sympathetic denervation.At the same time, we will use conventional therapy to protect cardiac function.then we will conduct a clinic follow-up and a telephone follow-up. Receives: Procedure: RSD; Other: Conventional therapy |
| Conventional therapy | Placebo comparator | We also will recruit 100 randomised CHF patients who meet the inclusion criteria.there are no significant differences in age,gender,race,past medical history,personal history and so on between the two groups.In this group we will use therapy just like the RSD+Conventional therapy group.we will conduct a clinic and a telephone follow-up. Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality,Cardiovascular events
To study effect of renal sympathetic denervation(RSD)on All-cause mortality ad cardiovascular events(cardiac death ,myocardial infarction ,malignant arrhythmia,angina and so on)
Measured: 24 months
Secondary outcomes (5)
Blood pressure
To study the effect of renal sympathetic denervation on blood pressure in patients with hypertension,which can be measured by ambulatory blood pressure and home pressure monitoring.
Measured: 24 months
Life quality and symptom
Life quality on 36-item short-form(SF-36)will be carried out during the follow-up to study the patients' life quality.Symptom will also be carried out by six walk distance during the follow-up,
Measured: 24 months
Rehospitalization rate
To study whether RSD can reduce the patients'rehospitalization rate because of heart failure,which will be measured by questionnaire and telephone follow-ups.
Measured: 24 months
The recurrence rate of electric storm with ICD
To study the recurrence rate of electric storm with ICD ,which will be measured by questionnaire and telephone follow-ups.
Measured: 24 months
Cardiac function an structure
The effect of renal sympathetic denervation(RSD)on cardiac function and structure can be measured by the six-minute walking test and echocardiographic(include left ventricular ejection fraction,left ventricular end diastolic diameter,ventricular septal thickness ), NYHA functional class,BNP(brain-type natriuretic peptide).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qijun Shan, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Shan Qijun, Professor, Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790906
- Sponsor's protocol ID
- 2013-SR-001
- Acronym
- RSD4CHF
- Status last verified
- Feb 2013
- First submitted
- 7 Feb 2013
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Study of Percutaneous Catheter-base Renal Sympathetic Denervation for Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01790906
- Acronym / sponsor ID
- RSD4CHF / 2013-SR-001
- Conditions
- Chronic Heart Failure
- Keywords
- Chronic Heart Failure, Renal Sympathetic Denervation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 13 Feb 2013 (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.
To study whether renal sympathetic denervation(RSD) RSD can slow the progression of CHF and reduce the rate of all-cause mortality effectively and securely.
Detailed description
Chronic heart failure(CHF) as the final stage of various heart diseases is a global and growing public health problem, and its morbidity increases with age. At present, the main therapies for CHF contain drug therapy (including angiotensin-converting enzyme inhibitors, aldosterone antagonist, beta-receptor blockers, diuretic, digoxin etc ) , CRT-D(cardiac resynchronization therapy )/ICD(implantable cardioverter-defibrillator), biological treatment, ultrafiltration dialysis, heart transplantation and so on. Optimize drug therapy is the foundation of CHF, but hypotension and bradycardia limit its indications. ESC(European Society of Cardiology)/AHA(American Heart Association) guidelines recommended CRT-P/D and ICD for drug resistant CHF, but the financial burden limit the use of them and some patients have no response to them. Donors and high costs are considered as two problems which limit heart transplantation appeal. Above all, we are always searching for a new treatment strategy for patients with chronic heart failure. Chronic over-activation of sympathetic nervous system is a major component of heart failure and involves efferent and afferent pathways between brain and many organs. Recently, some studies in animals and humans suggest that activation of both efferent and afferent renal nerves play a crucial role in the pathogenesis and progression of CHF. Activation of renal nerves in CHF may cause a reflex increase in sympathetic tone that contributes to elevated peripheral vascular resistance and vascular remodeling as well as left ventricular remodeling and dysfunction. Recently, many clinical trials have corroborated that catheter-based renal sympathetic denervation (RSD) significantly decreased sympathetic-nerve activity (MSNA) in muscle and whole-body, with a decrease in renal and whole-body norepinephrine spillover. Simultaneously, many clinical researches have also verified that RSD can safely be used to control hypertension, reduce left ventricular hypertrophy, improve glucose tolerance impaired ,decrease proteinuria and sleep apnea severity, which are all recognized as independent risk factors for the development and progression of CHF. Therefore, this randomized parallel control clinical trial was designed to demonstrate whether RSD can slow the progression of CHF and reduce the rate of all-cause mortality effectively and securely.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSD+Conventional therapy | Active comparator | Procedure: RSD, Other: Conventional therapyWe will recruit 100 randomised CHF patients who meet the inclusion criteria.First undergo renal artery angiography procedure to confirm anatomy.If renal artery meet the inclusion criteria,give the renal sympathetic denervation.At the same time, we will use conventional therapy to protect cardiac function.then we will conduct a clinic follow-up and a telephone follow-up. |
| Conventional therapy | Placebo comparator | Other: Conventional therapyWe also will recruit 100 randomised CHF patients who meet the inclusion criteria.there are no significant differences in age,gender,race,past medical history,personal history and so on between the two groups.In this group we will use therapy just like the RSD+Conventional therapy group.we will conduct a clinic and a telephone follow-up. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individual is ≥18 and ≤ 75 years of age
- Individual has a history of heart failure more than half a year
- Individual's Cardiac function is betweenⅡ-Ⅳlevel(NYHA)
- Ejection fraction ≦ 35%
- Renal artery CTA (computed tomographic arteriography)inspection renal artery length ≧ 2 cm, diameter ≧ 4 mm, no single double renal artery, renal artery start without distortion/tumor sample expansion,ect
Key exclusion criteria (10 listed)
- Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
- Individual has experienced renal artery stenosis,or A history of prior renal artery intervention including balloon angioplasty or stenting.
- Individual has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2, using the MDRD(Modification of Diet in Renal Disease) calculation.
- Individual has Acute heart failure.
- Individual has experienced a cerebrovascular accident within 3 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
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 |
|---|---|---|
| RSDAlso: renal sympathetic denervation, renal denervation, renal ablationContrast renal angiography was performed to localize and assess the renal arteries for accessibility and appropriateness for RSD .once the anatomy was deemed acceptable, the internally irrigated radiofrequency ablation catheter(Celsius Thermocool,Biosense Webster,Diamond Bar,California)was introduced into each renal artery.then was maneuvered within the renal artery to allow energy delivery in a circumferential,longitudinally staggered manner to minimize the chance of renal artery stenosis.About six to nine ablation at 10W for 1 min each were performed in both renal arteries.during ablation, the catheter system monitored tip temperature and impedance,altering radiofrequency energy delivery in response to predetermined algorithm. | Procedure or surgery | RSD+Conventional therapy |
| Conventional therapyOptimizing drug therapy,included angiotensin-converting enzyme inhibitors,aldosterone antagonist,beta-receptor blockers,diuretic,digoxin and so on.The patients with chronic heart failure ,whos'condition need for CRT-D(cardiac resynchronization therapy )/ICD(implantable cardioverter-defibrillator),are considered to implant CRT/ICD .CRT is abbreviation for cardiac resynchronization therapy ,ICD is defined for Implantable Cardioverter defibrillator. | Other | Conventional therapy, RSD+Conventional therapy |
Primary outcome
All-cause mortality,Cardiovascular events
Time frame: 24 months
To study effect of renal sympathetic denervation(RSD)on All-cause mortality ad cardiovascular events(cardiac death ,myocardial infarction ,malignant arrhythmia,angina and so on)
5 secondary outcomes
Blood pressure
Time frame: 24 months
Life quality and symptom
Time frame: 24 months
Rehospitalization rate
Time frame: 24 months
The recurrence rate of electric storm with ICD
Time frame: 24 months
Cardiac function an structure
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
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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.
Shan Qijun, Professor study chair
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RSD and Conventional therapy in people with Chronic Heart Failure, run by The First Affiliated Hospital with Nanjing 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 6 inclusion and 10 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 13 Feb 2013. 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. Some participants in this study may receive a placebo. 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 Shan Qijun, professor (02568136407, qjshan@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality,Cardiovascular events (time frame: 24 months). 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 13 Feb 2013.