Renal Sympathetic Denervation for Patients With Chronic Heart Failure

NCT01790906 | Unknown DMC

• 1 other identifier: 2013-SR-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To study whether renal sympathetic denervation(RSD) RSD can slow the progression of CHF and reduce the rate of all-cause mortality effectively and securely.

Conditions

Chronic Heart Failure

Keywords

Chronic Heart Failure; Renal Sympathetic Denervation

Outcome Measures

Primary Outcomes (1)

• All-cause mortality,Cardiovascular events

  To study effect of renal sympathetic denervation(RSD)on All-cause mortality ad cardiovascular events(cardiac death ,myocardial infarction ,malignant arrhythmia,angina and so on)

  24 months

Secondary Outcomes (5)

• Blood pressure

  24 months

• Life quality and symptom

  24 months

• Rehospitalization rate

  24 months

• The recurrence rate of electric storm with ICD

  24 months

• Cardiac function an structure

  24 months

Study Arms (2)

RSD+Conventional therapy

ACTIVE COMPARATOR

We will recruit 100 randomised CHF patients who meet the inclusion criteria.First undergo renal artery angiography procedure to confirm anatomy.If renal artery meet the inclusion criteria,give the renal sympathetic denervation.At the same time, we will use conventional therapy to protect cardiac function.then we will conduct a clinic follow-up and a telephone follow-up.

Procedure: RSD; Other: Conventional therapy

Conventional therapy

PLACEBO COMPARATOR

We also will recruit 100 randomised CHF patients who meet the inclusion criteria.there are no significant differences in age,gender,race,past medical history,personal history and so on between the two groups.In this group we will use therapy just like the RSD+Conventional therapy group.we will conduct a clinic and a telephone follow-up.

Other: Conventional therapy

Interventions

RSD 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 six to nine ablation at 10W for 1 min each were performed in both renal arteries.during ablation, the catheter system monitored tip temperature and impedance,altering radiofrequency energy delivery in response to predetermined algorithm.

Also known as: renal sympathetic denervation, renal denervation, renal ablation

RSD+Conventional therapy

Conventional therapy OTHER

Optimizing drug therapy,included angiotensin-converting enzyme inhibitors,aldosterone antagonist,beta-receptor blockers,diuretic,digoxin and so on.The patients with chronic heart failure ,whos'condition need for CRT-D(cardiac resynchronization therapy )/ICD(implantable cardioverter-defibrillator),are considered to implant CRT/ICD .CRT is abbreviation for cardiac resynchronization therapy ,ICD is defined for Implantable Cardioverter defibrillator.

Conventional therapy; RSD+Conventional therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual is ≥18 and ≤ 75 years of age
• Individual has a history of heart failure more than half a year
• Individual's Cardiac function is betweenⅡ-Ⅳlevel(NYHA)
• Ejection fraction ≦ 35%
• Renal artery CTA (computed tomographic arteriography)inspection renal artery length ≧ 2 cm, diameter ≧ 4 mm, no single double renal artery, renal artery start without distortion/tumor sample expansion,ect
• Individual agrees to have all study procedures performed and is competent and willing to provide written,informed consent to participate in this clinical study

You may not qualify if:

• Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
• Individual has experienced renal artery stenosis,or A history of prior renal artery intervention including balloon angioplasty or stenting.
• Individual has an estimated glomerular filtration rate (eGFR) of \< 45mL/min/1.73m2, using the MDRD(Modification of Diet in Renal Disease) calculation.
• Individual has Acute heart failure.
• Individual has experienced a cerebrovascular accident within 3 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
• Individual has experienced sick sinus syndrome.
• Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia, or arrhythmias such as atrial fibrillation).
• Individual is pregnant, nursing or planning to be pregnant. \[Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to treatment.\]
• Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
• Individual is currently enrolled in another investigational drug or device trial.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

First Affiliated Hospital of Nanjing Meddical University

Nanjing, Jiangsu, 210000, China

RECRUITING

Study Officials

• Shan Qijun, Professor

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Shan Qijun, professor

CONTACT

02568136407; 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: February 7, 2013
• First Posted: February 13, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: April 1, 2017
• Last Updated: February 13, 2013

Record last verified: 2013-02

Locations

CN (1)