- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01713270
Renal Sympathetic Denervation in Patients With Drug-resistant Hypertension and Symptomatic Atrial Fibrillation (RSDforAF)
July 4, 2013 updated by: Qijun Shan, The First Affiliated Hospital with Nanjing Medical University
Safety and Effectiveness Study of Percutaneous Catheter-based Renal Sympathetic Denervation in Patients With Drug-resistant Hypertension and Symptomatic Atrial Fibrillation
To study whether renal sympathetic denervation(RSD) is safe and effective in patients with drug-resistant hypertension and symptomatic atrial fibrillation.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Atrial fibrillation(AF) is the most common arrhythmia, and its frequency increases with age.
Hemodynamic impairment and thromboembolic events related to AF result in significant morbidity, mortality, and cost.
Management of patients with AF involves 3 objectives-correction of the rhythm disturbance, rate control, and prevention of thromboembolism.
Regardless of whether the rate-control or rhythm-control strategy is pursued, attention must also be directed to antithrombotic therapy for prevention of thromboembolism.
Pharmacological cardioversion approaches appear simple but are less efficacious.
The major risk is related to poor tolerance of side effects,drug-associated toxicity,and proarrhythmic potentia1 of antiarrhythmic drugs.
Radiofrequency catheter ablation of AF has developed rapidly in recent years, but the number of AF recurrences during the long-term follow-up was significant.
In addition, the complications associated with AF ablation procedures likely to result in prolonged hospitalization, long-term disability or death.
Hypertension is the most important risk factor for AF , Hypertension is associated with left ventricular hypertrophy, impaired ventricular filling, left atrial enlargement, and slowing of atrial conduction velocity.
These changes in cardiac structure and physiology favor the development and maintenance of AF, and they increase the risk of thromboembolic complications.
In patients with AF, aggressive treatment of hypertension may reverse the structural changes in the heart, reduce thromboembolic complications, and retard or prevent the occurrence of AF.
Recently, many clinical researches have verified that Catheter-based renal sympathetic denervation can safely be used to substantially reduce blood pressure, reduce left ventricular hypertrophy, improve glucose tolerance and sleep apnea severity.
Simultaneously, a marked reduction in muscle and whole-body sympathetic-nerve activity(MSNA) is apparent, with a decrease in renal and whole-body norepinephrine spillover.
Left ventricle hypertrophy, left atrial enlargement, high norepinephrine level,glucose tolerance abnormity and obstructive sleep apnea are all recognized as independent risk factors for the development and recurrence of AF.
So, we design this randomized parallel control multi center clinical study to demonstrate whether renal sympathetic denervation is safe and effective in patients with hypertension and symptomatic atrial fibrillation.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
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Nanjing,, Jiangsu, China, 210000
- Recruiting
- First Affiliated Hospital of Nanjing Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Individual is ≥18 and ≤75 years of age
- More than half a year for definite primary hypertension
- Individual has a systolic blood pressure ≥160 mmHg (≥150 mmHg for type 2 diabetics) based on an average of three office blood pressure readings measured
- Individual is adhering to a stable drug regimen, including three or more antihypertensive medications of which one is a diuretic, for a minimum of 14 days prior to enrollment
- At least 30 seconds on a rhythm strip in an ECG record and at least 1 AF outbreak which was recorded by EGG and Holter during the preceding 6 months
- Paroxysmal and persistent AF individual
- Agree to attend experimental clinic and sign written informed consent
Exclusion Criteria:
- Secondary and white-coat hypertension
- Permanent AF individual
- Thrombus in left atrial appendage found by transesophageal echocardiography
- Individual with severely enlarged left atria ≥55 mm
- Individual has experienced renal artery stenosis, or a history of prior renal artery intervention including balloon angioplasty or stenting, or ineligible conditions seen on renal artery computed tomography angiogram inspection such as double renal artery on one side, renal artery length ≤2 cm, diameter ≤4 mm, and distortion at incept sect
- Individual has experienced a definite acute coronary syndrome in the past 3 months, or a cerebrovascular accident and alimentary canal bleeding within 3 months
- Individual has experienced sick sinus syndrome
- reversible causes of AF, including alcohol abuse, surgery, electrocution, myocadial infarction, pericarditis, myocarditis, pulmonary embolism or other pulmonary diseases, hyperthyroidism, and other metabolic disorders
- structural heart diseases such as congenital, valvular heart diseases and kinds of cardiomyopathy
- Individual is pregnant or nursing
- Mental disorders - individual cannot complete follow-up or one the researcher thinks is unfit to be included in this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: renal sympathetic denervation
Contrast renal angiography was performed to localize and assess the renal arteries.
Once the anatomy was deemed acceptable, the internally irrigated radiofrequency ablation catheter was introduced into each renal artery.
This was then maneuvered within the renal artery to allow energy delivery in a circumferential, longitudinally staggered manner to minimize the chance of renal artery stenosis.
About four to eight ablations at 10 W for 60 seconds each were performed in both renal arteries.
After renal sympathetic denervation, patients with persistent AF accepted direct-current cardioversion immediately.
|
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 four to eight ablations at 10 W for 1 minute each were performed in both renal arteries.
During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm.
Other Names:
Angiotensin converting enzyme inhibitors, angiotensin receptor antagonist, calcium antagonists, diuretic, beta adrenoceptor blocking agents, propafenone, amiodarone
After renal sympathetic denervation, Persistent AF individual (except intracardiac thrombus) accept Direct-Current Cardioversion within one week.
anticoagulation (INR 2.0 to 3.0) is recommended for at least 3 weeks prior to and 4 weeks after cardioversion.
Other Names:
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Active Comparator: drug therapy
Patients in the drug treatment group will be followed-up at 3, 6, 9 and 12 months after randomization.
All the patients in this group will take their baseline antihypertensive medication at the original doses, without any changes except when medically required.
Antiarrhythmic drugs treatment is consistent in both arms.
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Angiotensin converting enzyme inhibitors, angiotensin receptor antagonist, calcium antagonists, diuretic, beta adrenoceptor blocking agents, propafenone, amiodarone
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in atrial fibrillation burden
Time Frame: from Baseline and 12 months
|
to demonstrate the effect of RSD on AF burden in patients with drug-resistant hypertension and symptomatic AF.
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from Baseline and 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
rate controlling in persistent AF patients
Time Frame: from baseline to 12 months
|
to demonstrate the effect of RSD on rate controlling in persistent AF patients from baseline to 12 months post-randomization,
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from baseline to 12 months
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office systolic blood pressure
Time Frame: from baseline to 12 months
|
the change in office systolic blood pressure from baseline to 12 months post-randomization
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from baseline to 12 months
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changes in cardiac structure and function,autonomic nerve function,fasting blood glucose, glycated hemoglobin, blood lipid, apnea-hypopnea index, pulse wave velocity and quality of life
Time Frame: from baseline to 12 months
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changes in cardiac structure and function by echocardiogram (include left ventricular ejection fraction, left ventricular end-diastolic diameter, interventricular septum, left atrium diameter), autonomic nerve function (heart rate variability by Holter), fasting blood glucose, glycated hemoglobin, blood lipid, apnea-hypopnea index, pulse wave velocity and quality of life.
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from baseline to 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Anticipated)
October 1, 2014
Study Completion (Anticipated)
July 1, 2015
Study Registration Dates
First Submitted
October 18, 2012
First Submitted That Met QC Criteria
October 22, 2012
First Posted (Estimate)
October 24, 2012
Study Record Updates
Last Update Posted (Estimate)
July 8, 2013
Last Update Submitted That Met QC Criteria
July 4, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-SR-080
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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