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Renal Sympathetic Denervation in Patients With Hypertension and Paroxysmal Atrial Fibrillation (RSDforPAF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01814111
Recruitment Status : Unknown
Verified March 2013 by Qijun Shan, The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : March 19, 2013
Last Update Posted : March 19, 2013
Information provided by (Responsible Party):
Qijun Shan, The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
The purpose of this study is to demonstrate whether renal sympathetic denervation is safe and effective in patients with hypertension and paroxysmal atrial fibrillation.

Condition or disease Intervention/treatment Phase
Hypertension Atrial Fibrillation Procedure: renal sympathetic denervation Not Applicable

Detailed Description:
Atrial fibrillation (AF) is one of the most common cardiac arrhythmia, complications of AF such as stroke, thromboembolism and heart failure will bring high disable rate and mortality , which will be serious influence on people's health and aggrandize medical financial burden, however, treatment for AF is not ideal. The affection of traditional antiarrhythmia drugs is not enough good, due to extra-heart bad reaction and potential arrhythmogenic substrate function restricted; rate control strategy applied quite abroad, however, anticoagulated medicine were not applied enough, Radiofrequency catheter ablation of AF has developed rapidly in recent years, But it's station is also disputed and its success rate is low and recrudescence is very high. meanwhile, serious complications will be caused. So far, hypertension is the most risk factor of AF. Long-term hypertension will change left-ventricle structure, through variability of pressure loading and capacity loading, damage diastolic function of left-ventricle. Increase of diastolic pressure in left-ventricle and atrial pressure will gradually result in atrial enlargement and fibrosis, so it will cause atrial fibrillation, repeating paroxysm or slow maintaining. Investigation indicated anti-hypertension therapy can decrease occurrence ratio and reoccurrence ratio of AF. Recently, many clinical researches have verified that renal sympathetic denervation acquired exact and sustained hypotension effect, In addition, Renal sympathetic denervation can reduce left ventricular hypertrophy, improve glucose metabolization and obstructive sleep, meanwhile, it reduce the level of nonepinephrine for both partial and whole-body. While left ventricle hypertrophy, left atrium enlarge,epinephrine over release itself and breath sleep obstacle are the independent dangerous factors of emerging AF. So ,we design this randomized parallel control multi center clinical study to demonstrate that renal sympathetic denervation is a safe and effective treatment for patients with hypertension and paroxysmal atrial fibrillation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness Study of Percutaneous Catheter-based Sympathetic Denervation of the Renal Arteries in Patients With Hypertension and Paroxysmal Atrial Fibrillation
Study Start Date : July 2012
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: renal sympathetic denervation
Perform renal angiogram immediately prior to renal sympathetic denervation procedure to confirm anatomic eligibility,The treatment catheter was introduced into each renal artery using a guiding catheter. Up to six ablations at 10 W for 1 min each were performed in both renal arteries. Treatments were delivered from the first distal main renal artery bifurcation to the ostium proximally and were spaced longitudinally and rotationally under fluoroscopic guidance. Catheter tip impedance and temperature were constantly monitored, and radio frequency energy delivery was regulated according to a predetermined algorithm. Visceral pain at the time of energy delivery was managed with intravenous analgetics and sedatives.
Procedure: renal sympathetic denervation
The ablation catheter was maneuvered within the renal artery to allow energy delivery in a circumferential, longitudinally staggered manner to minimize the chance of renal artery stenosis.

No Intervention: Drug Treatment Group
All the patients in this group will take their baseline antihypertensive medication at the original doses, without any changes except when medically required. AAD treatment is consistent in both arms.

Primary Outcome Measures :
  1. Change in atrial fibrillation burden [ Time Frame: baseline and 12 months ]
    The primary endpoint of this study is the Change in atrial fibrillation burden, atrial fibrillation burden was calculated as the median number of minutes in AF over a 24-hour period for each Holter recording

Secondary Outcome Measures :
  1. change in blood pressure [ Time Frame: baseline and 12 months ]
    change in Office systolic and diastolic blood pressure,

  2. Cardiac function and structure [ Time Frame: baseline and 12 months ]
    measure left ventricular ejection fractionleft,left ventricular end diastolic diameter, ventricular septal thickness, left atrium diameter by echocardiographic

  3. heart-rate-variability [ Time Frame: baseline and 12 months ]
    heart-rate-variability by Holter

  4. pulse wave velocity [ Time Frame: baseline and 12 months ]
  5. life quality on SF-36 Health Survey Questionnaire [ Time Frame: baseline and 12 months ]
  6. Blood biochemical examination Blood biochemical examination Blood biochemical examination [ Time Frame: baseline and 12 months ]
    include Fasting blood glucose, Glycated hemoglobin,Urinary protein

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Individual is ≥ 18 and ≤ 75 years of age.
  2. More than half a year for definite hypertension.
  3. AF is a common superventricular arrhythmia that is characterized by chaotic contraction of the atrium. An electrocardiogram (EGG) recording is necessary to diagnose AF. 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 in half a year.
  4. Paroxysmal AF Individual ,Paroxysmal AF is defined as recurrent AF (≧2 episodes) that terminates spontaneously within 7 days. Episodes of AF of ≤ 48 hours' duration that are terminated with electrical or pharmacologic cardioversion should also be classified as paroxysmal AF episodes.
  5. Individual eligible conditions through renal artery CTA inspection, such as undoubled renal artery on one side, renal artery length≧2cm, diameter≧4mm, and distortion at incept sect.
  6. Agree to attend clinic experiment and sign written informed consent.

Exclusion Criteria:

  1. Persistent AF Individual, Persistent AF is defined as continuous AF that is sustained beyond seven days. Episodes of AF in which a decision is made to electrically or pharmacologically cardiovert the patient after _≧48 hours of AF, but prior to 7 days, should also be classified as persistent AF episodes.
  2. Individual with Severely enlarged left atria≥ 55 mm
  3. Individual who reversibility mostly generated AF, such as abnormal hypothyroid or structural heart diseases
  4. 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 CTA inspection, such as double renal artery on one side, renal artery length≤2cm, diameter≤4mm, and distortion at incept sect.
  5. Individual has experienced a definite acute coronary syndrome in recent 3 months, or a cerebrovascular accident and alimentary canal bleeding within 3 months
  6. Individual has experienced sick sinus syndrome
  7. Pregnant Women or planning to be Pregnant Women, psychopathy Individual, individual who is sensitive to visualization, individual who can not cooperate with follow-up visit, or individual who researcher think it unsuitable to be included in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01814111

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China, Jiangsu
First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210000
Contact: qijun shan, professor    0086 025 68136407   
Principal Investigator: qijun shan, professor         
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
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Study Chair: qijun shan, Professor The First Affiliated Hospital with Nanjing Medical University
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Responsible Party: Qijun Shan, Professor,protomedicus and tutor for doctor in cardiovascular department, The First Affiliated Hospital with Nanjing Medical University Identifier: NCT01814111    
Other Study ID Numbers: 2012-SR-082
First Posted: March 19, 2013    Key Record Dates
Last Update Posted: March 19, 2013
Last Verified: March 2013
Keywords provided by Qijun Shan, The First Affiliated Hospital with Nanjing Medical University:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Additional relevant MeSH terms:
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Atrial Fibrillation
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes