Renal Sympathetic Denervation in Patients With Hypertension and Paroxysmal Atrial Fibrillation

Hypertension Clinical Trial

— RSDforPAF  

Official title:

Safety and Effectiveness Study of Percutaneous Catheter-based Sympathetic Denervation of the Renal Arteries in Patients With Hypertension and Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01814111
• Other study ID #: 2012-SR-082
• Status: Recruiting
• Phase: N/A
• First received: March 13, 2013
• Last updated: March 15, 2013
• Start date: July 2012
• Est. completion date: June 2015

Study information

• Verified date: March 2013
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Hypertension

Intervention

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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	change in blood pressure	change in Office systolic and diastolic blood pressure,	baseline and 12 months	No
Secondary	Cardiac function and structure	measure left ventricular ejection fractionleft,left ventricular end diastolic diameter, ventricular septal thickness, left atrium diameter by echocardiographic	baseline and 12 months	No
Secondary	heart-rate-variability	heart-rate-variability by Holter	baseline and 12 months	No
Secondary	pulse wave velocity		baseline and 12 months	No
Secondary	life quality on SF-36 Health Survey Questionnaire		baseline and 12 months	No
Secondary	Blood biochemical examination Blood biochemical examination Blood biochemical examination	include Fasting blood glucose, Glycated hemoglobin,Urinary protein	baseline and 12 months	No