Status:
UNKNOWN
Renal Sympathetic Modification in Patients With Heart Failure
Lead Sponsor:
The Second Affiliated Hospital of Chongqing Medical University
Collaborating Sponsors:
Jiangsu Provincial People's Hospital
Chongqing Medical University
Conditions:
Heart Failure
Eligibility:
All Genders
18-75 years
Phase:
NA
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 saf...
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 lon...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01402726
Start Date
July 1 2011
End Date
June 1 2020
Last Update
March 19 2019
Active Locations (1)
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1
2ndChongqingMU
Chongqing, Chongqing Municipality, China, 400010