Renal Sympathetic Modification in Patients With Heart Failure

Chongqing Medical University

Status

Unknown

Conditions

Heart Failure

Treatments

Procedure: renal sympathetic modification

Study type

Interventional

Funder types

Other

Identifiers

NCT01402726

SWAN-HF

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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