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Renal Sympathetic Modification in Patients With Heart Failure

This study is currently recruiting participants.
Verified May 2013 by The Second Affiliated Hospital of Chongqing Medical University
Sponsor:
Collaborators:
Jiangsu Provincial People's Hospital
Chongqing Medical University
Information provided by (Responsible Party):
Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT01402726
First received: July 25, 2011
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to observe the incident of composite cardiovascular events after renal sympathetic modification using THERMOCOOL® catheter in patients with heart failure, and evaluate safety and efficacy of the intervention.


Condition Intervention
Heart Failure
 Procedure: renal sympathetic modification

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Renal Sympathetic Modification in Patients With Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by The Second Affiliated Hospital of Chongqing Medical University:

Primary Outcome Measures:
  • composite cardiovascular events [ Time Frame: three years ] [ Designated as safety issue: Yes ]
    Comprising myocardial infarction, heart failure, sudden death, cardiogenic death


Estimated Enrollment: 200
Study Start Date: July 2011
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: renal sympathetic modification
Renal artery ablation to modify sympathetic activity in patients with heart failure.
 Procedure: renal sympathetic modification
Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure
Other Name: renal denervation
No Intervention: Absolute medicine therapy
Maintenance of anti-heart failure medications only

Detailed Description:

Heart failure is a clinical syndrome of chronic cardiac dysfunction, with high morbidity and mortality. Traditional pharmacological therapies are used in clinical practice without breakthrough for long time. Previous studies confirmed that partly blocking sympathetic nerves activity contributed to improve cardiac function in patients with heart failure. Renal ablation with sympathetic modification is a new method which is proved to be effective in decreasing sympathetic nerves activity. The investigators hypothesis that renal sympathetic nerves modification is effective and safe in improving cardiac function. This trial is going to recruit 200 patients (Ablation group VS Control group = 1:1) with a follow-up duration of 3 years. Patients in ablation group will receive additional necessary anti-heart failure drugs besides expectant intervention, and patients in control group will receive appropriate anti-heart failure drugs only. The investigators aim to observe the incident of composite cardiovascular events after renal sympathetic modification using THERMOCOOL® catheter in patients with heart failure, and evaluate safety and efficacy of the intervention.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 years old, and ≤ 75 years old of age
  • more than half a year history of heart failure, except for valvular heart disease
  • heart failure patients NYHA Class II III IV
  • left ventricular ejection function ≤ 40% or ≥ 45% (that is heart failure with preserved ejection fraction) with Simpson's method
  • estimated glomerular filtration rate (eGFR) of ≥ 45mL/min
  • is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion Criteria:

  • patients with acute heart failure
  • patients with acute coronary syndrome
  • estimated glomerular filtration rate (eGFR) of < 45mL/min
  • has the history of renal restenosis or renal stents implantation
  • has experienced AMI (old myocardial infarction is not excluded), unstable angina pectoris, cerebrovascular accidents, and alimentary tract hemorrhage within 3 months
  • patients with sick sinus syndrome
  • pregnant women
  • mental disorders
  • patients that have allergy to contrast agent
  • patients that do not go with follow-up
  • others such as researcher considers it is not appropriate to be included into the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402726

Contacts
Contact: Yuehui Yin, MD 0086-13508335502 yinyh63@163.com

Locations
China, Chongqing
2ndChongqingMU Recruiting
Chongqing, Chongqing, China, 400010
Contact: Yuehui Yin, MD     0086-13508335502     yinyh63@163.com    
Principal Investigator: Yuehui Yin, MD            
Sponsors and Collaborators
The Second Affiliated Hospital of Chongqing Medical University
Jiangsu Provincial People's Hospital
Chongqing Medical University
  More Information

No publications provided

Responsible Party: Yuehui Yin, Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center, The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT01402726     History of Changes
Other Study ID Numbers: SWAN-HF
Study First Received: July 25, 2011
Last Updated: May 2, 2013
Health Authority: China: Clinical Pharmacological Base of 2ndChongqingMU

Keywords provided by The Second Affiliated Hospital of Chongqing Medical University:
renal artery
sympathetic nerves
modification
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 13, 2013