Status:
UNKNOWN
Renal Sympathetic Denervation From the Adventitia on Resistant Hypertension（RSDARH）
Lead Sponsor:
Henan Institute of Cardiovascular Epidemiology
Conditions:
Resistant Hypertension
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT03758196
Start Date
October 31 2018
End Date
December 31 2021
Last Update
March 12 2020
Active Locations (1)
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1
Zhengzhou university People's Hospital
Zhengzhou, Henan, China