Renal Sympathetic Modification in Patients With Heart Failure
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.
|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|
- composite cardiovascular events [ Time Frame: three years ] [ Designated as safety issue: Yes ]Comprising myocardial infarction, heart failure, sudden death, cardiogenic death
|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)|
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
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.
|Contact: Yuehui Yin, MDfirstname.lastname@example.org|
|Chongqing, Chongqing, China, 400010|
|Contact: Yuehui Yin, MD 0086-13508335502 email@example.com|
|Principal Investigator: Yuehui Yin, MD|