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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 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:
NCT01814111
First received: March 13, 2013
Last updated: March 15, 2013
Last verified: March 2013
  Purpose

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 Intervention
Hypertension
Atrial Fibrillation
Procedure: renal sympathetic denervation

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 Sympathetic Denervation of the Renal Arteries in Patients With Hypertension and Paroxysmal 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: baseline and 12 months ] [ Designated as safety issue: No ]
    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:
  • change in blood pressure [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    change in Office systolic and diastolic blood pressure,

  • Cardiac function and structure [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    measure left ventricular ejection fractionleft,left ventricular end diastolic diameter, ventricular septal thickness, left atrium diameter by echocardiographic

  • heart-rate-variability [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    heart-rate-variability by Holter

  • pulse wave velocity [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • life quality on SF-36 Health Survey Questionnaire [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
  • Blood biochemical examination Blood biochemical examination Blood biochemical examination [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    include Fasting blood glucose, Glycated hemoglobin,Urinary protein


Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  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 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
  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: NCT01814111

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   
Principal Investigator: qijun shan, professor         
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,protomedicus and tutor for doctor in cardiovascular department, The First Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01814111     History of Changes
Other Study ID Numbers: 2012-SR-082
Study First Received: March 13, 2013
Last Updated: March 15, 2013
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Atrial Fibrillation
Hypertension
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014