Heart Failure
Conditions
Keywords
renal artery, sympathetic nerves, modification, heart failure
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.
Interventions
PROCEDURErenal sympathetic modification
Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure
Sponsors
Jiangsu Provincial People's Hospital
Chongqing Medical University
The Second Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| composite cardiovascular events | three years | Comprising myocardial infarction, heart failure, sudden death, cardiogenic death |
Countries
China
Contacts
Primary ContactYuehui Yin, MD
Outcome results
None listed