Renal Sympathetic Modification in Patients With Heart Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Renal Sympathetic Modification in Patients With Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Procedure: renal sympathetic modification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: renal sympathetic modification<br>Renal artery ablation to modify sympathetic activity in patients with heart failure. | Procedure: renal sympathetic modification<br>* Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure<br>* Other names: renal denervation;|
| No Intervention: Absolute medicine therapy<br>Maintenance of anti-heart failure medications only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite cardiovascular events | Comprising myocardial infarction, heart failure, sudden death, cardiogenic death | three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal artery, sympathetic nerves, modification, heart failure