Renal Sympathetic Denervation From the Adventitia on Resistant Hypertension（RSDARH）

Efficacy and Safety of Renal Sympathetic Denervation From the Adventitia on Resistant Hypertension.

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.

Study Overview

• Status: Unknown
• Conditions: Resistant Hypertension
• Intervention / Treatment: Device: Radiofrequency ablation instruments

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.

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Zhengzhou university People's Hospital
      • Contact: Chuanyu Gao, Dr; Phone Number: +86 13937165590; Email: gaocy6802@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Renal sympathetic denervation from the adventitia; Renal sympathetic denervation from the adventitia of renal artery and optimized medication regimen	Device: Radiofrequency ablation instruments; Renal Sympathetic Denervation from the adventitia of renal artery
No Intervention: optimized medication regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in 24-hour average systolic blood pressure by ABPM in 6 months after discharge .	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in types and doses of antihypertensive medications in 1,3,6,12 months after discharge.	Baseline to 1 months,3 months,6 months,12 months
Change in 24-hour average diastolic blood pressure,daytime and nighttime systolic/diastolic blood pressure by ABPM in 6 months after discharge	Baseline to 6 months
Change in 24-hour average blood pressure,daytime and nighttime systolic/diastolic blood pressure by ABPM in 1,3,12 months after discharge	Baseline to 1 months,3 months,12 months
Change in office systolic/diastolic blood pressure in 1,3,6,12 months after discharge	Baseline to 1 months,3 months,6 months,12 months
Change in systolic/diastolic blood pressure by home blood pressure monitoring in 1,3,6,12 months after discharge	Baseline to 1 months,3 months,6 months,12 months
renal function in 1,3,6,12 months after discharge	Baseline to 1 months,3 months,6 months,12 months
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.	Baseline to 6 months,12 months

Collaborators and Investigators

• Sponsor: Henan Institute of Cardiovascular Epidemiology
• Investigators: Principal Investigator: Chuanyu Gao, Dr., Henan Provincial People's Hospital; Principal Investigator: Jiguang Huang, Dr., Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine;Shanghai Institute of Hypertension

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (Actual): November 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: resistant hypertension; renal sympathetic denervation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: HenanICE201802

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No