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The purpose of this study is to demonstrate whether renal sympathetic denervation is safe and effective in patients with hypertension and paroxysmal atrial fibrillation.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| renal sympathetic denervation | Experimental | 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. |
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| Drug Treatment Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| renal sympathetic denervation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in atrial fibrillation burden | 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 | baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in blood pressure | change in Office systolic and diastolic blood pressure, | baseline and 12 months |
| Cardiac function and structure | measure left ventricular ejection fractionleft，left ventricular end diastolic diameter, ventricular septal thickness, left atrium diameter by echocardiographic |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| qijun shan, Professor | The First Affiliated Hospital with Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| baseline and 12 months |
| heart-rate-variability | heart-rate-variability by Holter | baseline and 12 months |
| pulse wave velocity | baseline and 12 months |
| life quality on SF-36 Health Survey Questionnaire | baseline and 12 months |
| Blood biochemical examination Blood biochemical examination Blood biochemical examination | include Fasting blood glucose, Glycated hemoglobin，Urinary protein | baseline and 12 months |