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

Primary Purpose

Resistant Hypertension

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Radiofrequency ablation instruments

About this trial

This is an interventional treatment trial for Resistant Hypertension focused on measuring renal sympathetic denervation, resistant hypertension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Patients with secondary hypertension caused by any known cause;
pregnant or planning to be pregnant;
Patients with renal artery diameter <4mm or length <20mm;
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;
Patients with cardiovascular instability factors includes:acute myocardial infarction within six months,unstable angina or cerebrovascular disease;heart valve disease with significantly altered hemodynamics;
Patients with other serious organic diseases;
Patients participated in other studies.

Sites / Locations

Zhengzhou university People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Renal sympathetic denervation from the adventitia

optimized medication regimen

Arm Description

Renal sympathetic denervation from the adventitia of renal artery and optimized medication regimen

optimized medication regimen

Outcomes

Primary Outcome Measures

Change in 24-hour average systolic blood pressure by ABPM in 6 months after discharge .

Secondary Outcome Measures

Change in types and doses of antihypertensive medications in 1,3,6,12 months after discharge.

Change in 24-hour average diastolic blood pressure,daytime and nighttime systolic/diastolic blood pressure by ABPM in 6 months after discharge

Change in 24-hour average blood pressure,daytime and nighttime systolic/diastolic blood pressure by ABPM in 1,3,12 months after discharge

Change in office systolic/diastolic blood pressure in 1,3,6,12 months after discharge

Change in systolic/diastolic blood pressure by home blood pressure monitoring in 1,3,6,12 months after discharge

renal function in 1,3,6,12 months after discharge

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.

Full Information

NCT ID

NCT03758196

First Posted

November 27, 2018

Last Updated

March 11, 2020

Sponsor

Henan Institute of Cardiovascular Epidemiology

1. Study Identification

Unique Protocol Identification Number

NCT03758196

Brief Title

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

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 31, 2018 (Actual)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Henan Institute of Cardiovascular Epidemiology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Resistant Hypertension

Keywords

renal sympathetic denervation, resistant hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Renal sympathetic denervation from the adventitia

Arm Type

Experimental

Arm Description

Renal sympathetic denervation from the adventitia of renal artery and optimized medication regimen

Arm Title

optimized medication regimen

Arm Type

No Intervention

Arm Description

optimized medication regimen

Intervention Type

Device

Intervention Name(s)

Radiofrequency ablation instruments

Intervention Description

Renal Sympathetic Denervation from the adventitia of renal artery

Primary Outcome Measure Information:

Title

Change in 24-hour average systolic blood pressure by ABPM in 6 months after discharge .

Time Frame

Baseline to 6 months

Secondary Outcome Measure Information:

Title

Change in types and doses of antihypertensive medications in 1,3,6,12 months after discharge.

Time Frame

Baseline to 1 months,3 months,6 months,12 months

Title

Change in 24-hour average diastolic blood pressure,daytime and nighttime systolic/diastolic blood pressure by ABPM in 6 months after discharge

Time Frame

Baseline to 6 months

Title

Change in 24-hour average blood pressure,daytime and nighttime systolic/diastolic blood pressure by ABPM in 1,3,12 months after discharge

Time Frame

Baseline to 1 months,3 months,12 months

Title

Change in office systolic/diastolic blood pressure in 1,3,6,12 months after discharge

Time Frame

Baseline to 1 months,3 months,6 months,12 months

Title

Change in systolic/diastolic blood pressure by home blood pressure monitoring in 1,3,6,12 months after discharge

Time Frame

Baseline to 1 months,3 months,6 months,12 months

Title

renal function in 1,3,6,12 months after discharge

Time Frame

Baseline to 1 months,3 months,6 months,12 months

Title

Time Frame

Baseline to 6 months,12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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: Patients with secondary hypertension caused by any known cause; pregnant or planning to be pregnant; Patients with renal artery diameter <4mm or length <20mm; 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; Patients with cardiovascular instability factors includes:acute myocardial infarction within six months,unstable angina or cerebrovascular disease;heart valve disease with significantly altered hemodynamics; Patients with other serious organic diseases; Patients participated in other studies.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yahui Liu, Bachelor

Phone

+86 18317898825

1182600873@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Chuanyu Gao, Dr.

Phone

+86 13937165590

gaocy6802@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chuanyu Gao, Dr.

Organizational Affiliation

Henan Provincial People's Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jiguang Huang, Dr.

Organizational Affiliation

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine;Shanghai Institute of Hypertension

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhengzhou university People's Hospital

City

Zhengzhou

State/Province

Henan

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chuanyu Gao, Dr

Phone

+86 13937165590

gaocy6802@163.com

12. IPD Sharing Statement

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

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