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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 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: July 4, 2013
Last verified: July 2013
  Purpose

To study whether renal sympathetic denervation(RSD) is safe and effective in patients with drug-resistant 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 Drug-resistant 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 [ Time Frame: from Baseline and 12 months ] [ Designated as safety issue: Yes ]
    to demonstrate the effect of RSD on AF burden in patients with drug-resistant hypertension and symptomatic AF.


Secondary Outcome Measures:
  • rate controlling in persistent AF patients [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: Yes ]
    to demonstrate the effect of RSD on rate controlling in persistent AF patients from baseline to 12 months post-randomization,

  • office systolic blood pressure [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: Yes ]
    the change in office systolic blood pressure from baseline to 12 months post-randomization

  • 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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 200
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
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.
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(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:
  • renal denervation
  • renal ablation
Drug: drug
Angiotensin converting enzyme inhibitors, angiotensin receptor antagonist, calcium antagonists, diuretic, beta adrenoceptor blocking agents, propafenone, amiodarone
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 weeks prior to and 4 weeks after cardioversion.
Other Name: Cardioversion
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.
Drug: drug
Angiotensin converting enzyme inhibitors, angiotensin receptor antagonist, calcium antagonists, diuretic, beta adrenoceptor blocking agents, propafenone, amiodarone

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. 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
  4. 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
  5. 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
  6. Paroxysmal and persistent AF individual
  7. Agree to attend experimental clinic and sign written informed consent

Exclusion Criteria:

  1. Secondary and white-coat hypertension
  2. Permanent AF individual
  3. Thrombus in left atrial appendage found by transesophageal echocardiography
  4. Individual with severely enlarged left atria ≥55 mm
  5. 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
  6. Individual has experienced a definite acute coronary syndrome in the past 3 months, or a cerebrovascular accident and alimentary canal bleeding within 3 months
  7. Individual has experienced sick sinus syndrome
  8. reversible causes of AF, including alcohol abuse, surgery, electrocution, myocadial infarction, pericarditis, myocarditis, pulmonary embolism or other pulmonary diseases, hyperthyroidism, and other metabolic disorders
  9. structural heart diseases such as congenital, valvular heart diseases and kinds of cardiomyopathy
  10. Individual is pregnant or nursing
  11. Mental disorders - individual cannot complete follow-up or one the researcher thinks is unfit to be included in this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by The First Hospital of Nanjing Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: July 4, 2013
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
Angiotensin-Converting Enzyme Inhibitors
Angiotensin Receptor Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014