Renal Sympathetic Denervation in Patients With Hypertension and Paroxysmal Atrial Fibrillation (RSDforPAF)
The purpose of this study is to demonstrate whether renal sympathetic denervation is safe and effective in patients with hypertension and paroxysmal atrial fibrillation.
|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|
- 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
- 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
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01814111
|First Affiliated Hospital of Nanjing Medical University||Recruiting|
|Nanjing, Jiangsu, China, 210000|
|Contact: qijun shan, professor 0086 025 68136407 email@example.com|
|Principal Investigator: qijun shan, professor|
|Study Chair:||qijun shan, Professor||the First Affiliated Hospital of Nanjing Medical University|