Clinical trial NCT03758196: Renal Sympathetic Denervation From the Adventitia on Resistant Hypertension（RSDARH）
Official title: Efficacy and Safety of Renal Sympathetic Denervation From the Adventitia on Resistant Hypertension.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Resistant Hypertension
Keywords: renal sympathetic denervation
resistant hypertension
Lead sponsor: Henan Institute of Cardiovascular Epidemiology
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As one of the most common chronic diseases,The adult prevalence of hypertension is approximately 26.4% at present and will rise to 29.2% by 2025.Renal sympathetic denervation from the intima of renal artery has emerged as a potential treatment for resistant hypertension. However, renal sympathetic nerve are mainly located in the adventitia,and there is no report on renal sympathetic denervation from the adventitia of renal artery.This study is a multicenter,randomized,single-blind study,and aimed to observe the safety and efficacy of radiofrequency ablation of the renal artery from the adventitia on the basis of laparoscopic techniques for patients with resistant hypertension.

Detailed description: This study is a multicenter,randomized,single-blind study,and aimed to observe the safety and efficacy of radiofrequency ablation of the renal artery from the adventitia on the basis of laparoscopic techniques for patients with resistant hypertension.

Eligibility criteria: Inclusion Criteria:

1.18 years old ≤ age ≤ 65 years old; 2.Patients with clear diagnosis of resistant hypertension prior to enrollment：On the basis of improving lifestyle, a reasonable and tolerable amount of 3 or more kinds of antihypertensive drugs (including diuretics) for more than one month, clinic SBP≥140mmHg or (and) DBP≥90mmHg, 24 hours dynamic Blood pressure monitoring SBP\>130mmHg or (and) DBP\>80mmHg; 3.Estimated GFR (eGFR) ≥ 60ml/min/1.73m2; 4.The patient or his legal guardian has signed the informed consent; 5.Patients who are willing and able to perform follow-up visits.

Exclusion Criteria:

1. Patients with secondary hypertension caused by any known cause;
2. pregnant or planning to be pregnant;
3. Patients with renal artery diameter \<4mm or length \<20mm;
4. Patients with renal artery abnormalities include: hemodynamic or anatomically significant stenosis (≥50%) of renal arteries on either side;renal arterial balloon angioplasty or stenting;renal involvement on either side Multiple renal arteries,and renal arteries supply \<75% of the kidneys;abnormal renal artery anatomy,such as tumor expansion;
5. Patients with cardiovascular instability factors includes:acute myocardial infarction within six months,unstable angina or cerebrovascular disease;heart valve disease with significantly altered hemodynamics;
6. Patients with other serious organic diseases;
7. Patients participated in other studies.

Primary outcomes:
measure: Change in 24-hour average systolic blood pressure by ABPM in 6 months after discharge .
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in types and doses of antihypertensive medications in 1,3,6,12 months after discharge.
timeFrame: Baseline to 1 months,3 months,6 months,12 months
measure: Change in 24-hour average diastolic blood pressure,daytime and nighttime systolic/diastolic blood pressure by ABPM in 6 months after discharge
timeFrame: Baseline to 6 months
measure: Change in 24-hour average blood pressure,daytime and nighttime systolic/diastolic blood pressure by ABPM in 1,3,12 months after discharge
timeFrame: Baseline to 1 months,3 months,12 months
measure: Change in office systolic/diastolic blood pressure in 1,3,6,12 months after discharge
timeFrame: Baseline to 1 months,3 months,6 months,12 months
measure: Change in systolic/diastolic blood pressure by home blood pressure monitoring in 1,3,6,12 months after discharge
timeFrame: Baseline to 1 months,3 months,6 months,12 months
measure: renal function in 1,3,6,12 months after discharge
timeFrame: Baseline to 1 months,3 months,6 months,12 months
measure: The surgical complications of renal artery perforation,such as stenosis,and dissection associated with radiofrequency surgery.And major cardiovascular and cerebrovascular events ,including cardiac death,stroke and nonfatal- myocardial infarction.
timeFrame: Baseline to 6 months,12 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Zhengzhou university People's Hospital
state: Henan
Study officials:
affiliation: Henan Provincial People's Hospital
name: Chuanyu Gao, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine;Shanghai Institute of Hypertension
name: Jiguang Huang, Dr.
role: PRINCIPAL_INVESTIGATOR
References: