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

NCT03758196 | Unknown

• 1 other identifier: HenanICE201802
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Resistant Hypertension

Keywords

renal sympathetic denervation; resistant hypertension

Outcome Measures

Primary Outcomes (1)

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

  Baseline to 6 months

Secondary Outcomes (7)

• 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

Study Arms (2)

Renal sympathetic denervation from the adventitia

EXPERIMENTAL

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

Device: Radiofrequency ablation instruments

optimized medication regimen

NO INTERVENTION

optimized medication regimen

Interventions

Radiofrequency ablation instruments DEVICE

Renal Sympathetic Denervation from the adventitia of renal artery

Renal sympathetic denervation from the adventitia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

Study Sites (1)

Zhengzhou university People's Hospital

Zhengzhou, Henan, China

RECRUITING

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yahui Liu, Bachelor

CONTACT

+86 18317898825; 1182600873@qq.com

Chuanyu Gao, Dr.

CONTACT

+86 13937165590; gaocy6802@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 29, 2018
• Study Start: October 31, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: March 12, 2020

Record last verified: 2020-03

Locations

CN (1)