Renal Sympathetic Modification in Patients With Heart Failure

Not Applicable

• Conditions: Heart Failure
• Interventions: Procedure: renal sympathetic modification

• Registration Number: NCT01402726
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-19
• Primary Completion: 2019-12
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
renal sympathetic modification	renal sympathetic modification	Renal artery ablation to modify sympathetic activity in patients with heart failure.

Primary Outcome Measures

Name	Time	Method
composite cardiovascular events	three years	Comprising myocardial infarction, heart failure, sudden death, cardiogenic death

Trial Locations

Locations (1)

2ndChongqingMU; 🇨🇳 Chongqing, Chongqing, China