Renal Sympathetic Modification in Patients With Heart Failure
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
renal sympathetic modification
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring renal artery, sympathetic nerves, modification, heart failure
Eligibility 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
Sites / Locations
- 2ndChongqingMURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
renal sympathetic modification
Absolute medicine therapy
Arm Description
Renal artery ablation to modify sympathetic activity in patients with heart failure.
Maintenance of anti-heart failure medications only
Outcomes
Primary Outcome Measures
composite cardiovascular events
Comprising myocardial infarction, heart failure, sudden death, cardiogenic death
Secondary Outcome Measures
Full Information
NCT ID
NCT01402726
First Posted
July 25, 2011
Last Updated
March 18, 2019
Sponsor
The Second Affiliated Hospital of Chongqing Medical University
Collaborators
Jiangsu Provincial People's Hospital, Chongqing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01402726
Brief Title
Renal Sympathetic Modification in Patients With Heart Failure
Official Title
Renal Sympathetic Modification in Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Affiliated Hospital of Chongqing Medical University
Collaborators
Jiangsu Provincial People's Hospital, Chongqing Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
renal artery, sympathetic nerves, modification, heart failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
renal sympathetic modification
Arm Type
Experimental
Arm Description
Renal artery ablation to modify sympathetic activity in patients with heart failure.
Arm Title
Absolute medicine therapy
Arm Type
No Intervention
Arm Description
Maintenance of anti-heart failure medications only
Intervention Type
Procedure
Intervention Name(s)
renal sympathetic modification
Other Intervention Name(s)
renal denervation
Intervention Description
Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure
Primary Outcome Measure Information:
Title
composite cardiovascular events
Description
Comprising myocardial infarction, heart failure, sudden death, cardiogenic death
Time Frame
three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuehui Yin, MD
Phone
0086-13508335502
Email
yinyh63@163.com
Facility Information:
Facility Name
2ndChongqingMU
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuehui Yin, MD
Phone
0086-13508335502
Email
yinyh63@163.com
First Name & Middle Initial & Last Name & Degree
Yuehui Yin, MD
12. IPD Sharing Statement
Learn more about this trial
Renal Sympathetic Modification in Patients With Heart Failure
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