Renal Sympathetic Denervation in Patients With Hypertension and Symptomatic Atrial Fibrillation (RSDforAF)

This study is currently recruiting participants.
Verified October 2012 by The First Hospital of Nanjing Medical University
Sponsor:
Information provided by (Responsible Party):
Qijun Shan, The First Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01713270
First received: October 18, 2012
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

To study whether renal sympathetic denervation(RSD) is safe and effective in patients with hypertension and symptomatic atrial fibrillation.


Condition Intervention
Hypertension
Atrial Fibrillation
Procedure: renal sympathetic denervation
Drug: drug
Procedure: Direct-Current Cardioversion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness Study of Percutaneous Catheter-based Renal Sympathetic Denervation in Patients With Hypertension and Symptomatic Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by The First Hospital of Nanjing Medical University:

Primary Outcome Measures:
  • Change in atrial fibrillation burden and blood pressure [ Time Frame: from Baseline and 12 months ] [ Designated as safety issue: Yes ]
    To study the effect of renal sympathetic denervation on atrial fibrillation burden and blood pressure in patients with hypertension and symptomatic atrial fibrillation


Secondary Outcome Measures:
  • Cardiac function and structure,autonomic nerve function,apnea-hypopnea index and pulse wave velocity ,life quality and laboratory examination [ Time Frame: from Baseline and 12 months ] [ Designated as safety issue: Yes ]
    the effect of renal sympathetic denervation on cardiac function and structure by echocardiographic(include left ventricular ejection fraction,left ventricular end diastolic diameter, ventricular septal thickness, left atrium diameter),and autonomic nerve function(heart-rate-variability by Holter), fasting blood glucose, glycated hemoglobin,urinary protein,apnea-hypopnea index and pulse wave velocity (PWV), life quality on 36-item short-form(SF-36)Health Survey Questionnaire.


Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: renal sympathetic denervation
Preparing before renal sympathetic denervation,Perform renal angiogram immediately prior to renal sympathetic denervation procedure to confirm anatomy ,the renal sympathetic denervation procedure,renal angiogram after renal sympathetic denervation procedure. 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 wk prior to and 4 wk after cardioversion.
Procedure: renal sympathetic denervation
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(Celcius 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 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 a predetermined algorithm.
Other Names:
  • renal denervation
  • renal ablation
Drug: drug
Angiotensin converting enzyme inhibitors,angiotensin receptor antagonist,calcium antagonists,diuretic,beta adrenoceptor blocking agents,propafenone
Procedure: Direct-Current Cardioversion
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 wk prior to and 4 wk after cardioversion.
Other Name: Cardioversion
Active Comparator: drug therapy
Participants should continue to receive drug therapy ,include angiotensin converting enzyme inhibitors,angiotensin receptor antagonist,calcium antagonists,diuretic,beta adrenoceptor blocking agents,propafenone
Drug: drug
Angiotensin converting enzyme inhibitors,angiotensin receptor antagonist,calcium antagonists,diuretic,beta adrenoceptor blocking agents,propafenone

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Individual is ≥ 18 and ≤75 years of age.
  2. More than half a year for definite primary hypertension.
  3. At least 30 seconds on a rhythm strip in an EGG record and at least 1 AF outbreak which was recorded by EGG and Holter during the preceding 6 months.
  4. Paroxysmal and Persistent AF individual.
  5. except Reversible Causes of Atrial Fibrillation,including alcohol intake, surgery, electrocution, myocardial infarction, pericarditis, myocarditis, pulmonary embolism or other pulmonary diseases, hyperthyroidism, and other metabolic disorders.
  6. except structural heart diseases such as congenital, valvular heart diseases and kinds of cardiomyopathy.
  7. Agree to attend clinic experiment and sign written informed consent.

Exclusion Criteria:

  1. Individual with Severely enlarged left atria≥ 55 mm.
  2. transesophageal echocardiography found thrombus in left atrial appendage
  3. Individual has experienced renal artery stenosis ,or A history of prior renal artery intervention including balloon angioplasty or stenting. or ineligible conditions through renal artery Computed Tomography Angiogram( CTA) inspection, such as double renal artery on one side, renal artery length≤2cm, diameter≤4mm, and distortion at incept sect.
  4. Individual has experienced a definite acute coronary syndrome in recent 3 months, or a cerebrovascular accident and alimentary canal bleeding within 3 months.
  5. Individual has experienced sick sinus syndrome.
  6. Individual is pregnant or nursing.
  7. mental disorders, individual who can not go with follow-up , or individual who researcher think it inappropriate to be included into the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713270

Contacts
Contact: Qijun Shan, professor 0086 025 68136407 qjshan@njmu.edu.cn

Locations
China, Jiangsu
First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing,, Jiangsu, China, 210000
Contact: Qijun Shan, professor     0086 025 68136407     qjshan@njmu.edu.cn    
Sponsors and Collaborators
The First Hospital of Nanjing Medical University
Investigators
Study Chair: Qijun Shan, professor the First Affiliated Hospital of Nanjing Medical University
  More Information

No publications provided

Responsible Party: Qijun Shan, Professor,Director, Cardiac Arrhythmia Group, The First Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01713270     History of Changes
Other Study ID Numbers: 2012-SR-080
Study First Received: October 18, 2012
Last Updated: October 22, 2012
Health Authority: China: Ethics Committee

Keywords provided by The First Hospital of Nanjing Medical University:
Hypertension
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases

Additional relevant MeSH terms:
Atrial Fibrillation
Hypertension
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Adrenergic beta-Antagonists
Angiotensin-Converting Enzyme Inhibitors
Calcium Channel Blockers
Enzyme Inhibitors
Angiotensin Receptor Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Membrane Transport Modulators
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013