Essential Hypertension
Conditions
Keywords
renal artery, sympathetic nerves, modification, essential hypertension, primary hypertension
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 essential hypertension, and evaluate safety and efficacy of the intervention.
Detailed description
Hypertension is a common cardiovascular disease, and is also an important risk factor for heart-brain-renal diseases, with relatively low controlled rate. Traditional pharmacological therapies are used in clinical practice without breakthrough for long time. Previous studies confirmed that sympathetic nerves activity contributed to development and perpetuation of hypertension. Renal ablation for sympathetic modification is a new method which is proved to be effective in decreasing sympathetic nerves activity. We assume that modifying renal sympathetic activity by ablation is effective and safe in treatment of hypertension. 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-hypertensive medications besides expectant intervention, and patients in control group will receive appropriate anti-hypertensive medications only. We aim to observe the incident of composite cardiovascular events after renal sympathetic modification using THERMOCOOL® catheter in patients with hypertension, 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
Zunyi Medical College
Chongqing Medical University
The Second Affiliated Hospital of Chongqing Medical University
Study design
Allocation
NON_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 hypertension, except for valvular heart disease * recently at least three times office blood pressure suggest systolic blood pressure of 140mmHg or more and/or a diastolic blood pressure of 90mmHg or more * 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
* secondary hypertension * isolated systolic hypertension * 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, stroke, heart failure, sudden death |
Countries
China
Contacts
Primary ContactYuehui Yin, MD
Outcome results
None listed