Renal Sympathetic Denervation in Patients With Drug-resistant Hypertension and Symptomatic Atrial Fibrillation

NCT01713270 | Unknown DMC

• 1 other identifier: 2012-SR-080
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To study whether renal sympathetic denervation(RSD) is safe and effective in patients with drug-resistant hypertension and symptomatic atrial fibrillation.

Conditions

Hypertension; Atrial Fibrillation

Keywords

Hypertension; Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases

Outcome Measures

Primary Outcomes (1)

• Change in atrial fibrillation burden

  to demonstrate the effect of RSD on AF burden in patients with drug-resistant hypertension and symptomatic AF.

  from Baseline and 12 months

Secondary Outcomes (3)

• rate controlling in persistent AF patients

  from baseline to 12 months

• office systolic blood pressure

  from baseline to 12 months

• changes in cardiac structure and function,autonomic nerve function,fasting blood glucose, glycated hemoglobin, blood lipid, apnea-hypopnea index, pulse wave velocity and quality of life

  from baseline to 12 months

Study Arms (2)

renal sympathetic denervation

EXPERIMENTAL

Contrast renal angiography was performed to localize and assess the renal arteries. Once the anatomy was deemed acceptable, the internally irrigated radiofrequency ablation catheter was introduced into each renal artery. This was then maneuvered within the renal artery to allow energy delivery in a circumferential, longitudinally staggered manner to minimize the chance of renal artery stenosis. About four to eight ablations at 10 W for 60 seconds each were performed in both renal arteries. After renal sympathetic denervation, patients with persistent AF accepted direct-current cardioversion immediately.

Procedure: renal sympathetic denervation; Drug: drug; Procedure: Direct-Current Cardioversion

drug therapy

ACTIVE COMPARATOR

Patients in the drug treatment group will be followed-up at 3, 6, 9 and 12 months after randomization. All the patients in this group will take their baseline antihypertensive medication at the original doses, without any changes except when medically required. Antiarrhythmic drugs treatment is consistent in both arms.

Drug: drug

Interventions

renal sympathetic denervation PROCEDURE

Contrast renal angiography was performed to localize and assess the renal arteries for accessibility and appropriateness for RSD. Once the anatomy was deemed acceptable, the internally irrigated radiofrequency ablation catheter(Celsius Thermocool, Biosense Webster, Diamond Bar, California) was introduced into each renal artery. then was maneuvered within the renal artery to allow energy delivery in a circumferential, longitudinally staggered manner to minimize the chance of renal artery stenosis. About four to eight ablations at 10 W for 1 minute each were performed in both renal arteries. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm.

Also known as: renal denervation, renal ablation

renal sympathetic denervation

drug DRUG

Angiotensin converting enzyme inhibitors, angiotensin receptor antagonist, calcium antagonists, diuretic, beta adrenoceptor blocking agents, propafenone, amiodarone

drug therapy; renal sympathetic denervation

Direct-Current Cardioversion PROCEDURE

After renal sympathetic denervation, Persistent AF individual (except intracardiac thrombus) accept Direct-Current Cardioversion within one week. anticoagulation (INR 2.0 to 3.0) is recommended for at least 3 weeks prior to and 4 weeks after cardioversion.

Also known as: Cardioversion

renal sympathetic denervation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual is ≥18 and ≤75 years of age
• More than half a year for definite primary hypertension
• Individual has a systolic blood pressure ≥160 mmHg (≥150 mmHg for type 2 diabetics) based on an average of three office blood pressure readings measured
• Individual is adhering to a stable drug regimen, including three or more antihypertensive medications of which one is a diuretic, for a minimum of 14 days prior to enrollment
• At least 30 seconds on a rhythm strip in an ECG record and at least 1 AF outbreak which was recorded by EGG and Holter during the preceding 6 months
• Paroxysmal and persistent AF individual
• Agree to attend experimental clinic and sign written informed consent

You may not qualify if:

• Secondary and white-coat hypertension
• Permanent AF individual
• Thrombus in left atrial appendage found by transesophageal echocardiography
• Individual with severely enlarged left atria ≥55 mm
• Individual has experienced renal artery stenosis, or a history of prior renal artery intervention including balloon angioplasty or stenting, or ineligible conditions seen on renal artery computed tomography angiogram inspection such as double renal artery on one side, renal artery length ≤2 cm, diameter ≤4 mm, and distortion at incept sect
• Individual has experienced a definite acute coronary syndrome in the past 3 months, or a cerebrovascular accident and alimentary canal bleeding within 3 months
• Individual has experienced sick sinus syndrome
• reversible causes of AF, including alcohol abuse, surgery, electrocution, myocadial infarction, pericarditis, myocarditis, pulmonary embolism or other pulmonary diseases, hyperthyroidism, and other metabolic disorders
• structural heart diseases such as congenital, valvular heart diseases and kinds of cardiomyopathy
• Individual is pregnant or nursing
• Mental disorders - individual cannot complete follow-up or one the researcher thinks is unfit to be included in this study

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (1)

• Qiu M, Yin Y, Shan Q. Renal sympathetic denervation versus antiarrhythmic drugs for drug-resistant hypertension and symptomatic atrial fibrillation (RSDforAF) trial: study protocol for a randomized controlled trial. Trials. 2013 Jun 11;14:168. doi: 10.1186/1745-6215-14-168.

  PMID: 23759000 DERIVED

MeSH Terms

Conditions

Hypertension; Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases

Interventions

Pharmaceutical Preparations; Electric Countershock

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Qijun Shan, professor

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Qijun Shan, professor

CONTACT

0086 025 68136407; qjshan@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor，Director, Cardiac Arrhythmia Group

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 24, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: July 1, 2015
• Last Updated: July 8, 2013

Record last verified: 2013-07

Locations

CN (1)