Resistant HypertensionNCT03758196
Renal Sympathetic Denervation From the Adventitia on Resistant Hypertension（RSDARH）
A study testing Radiofrequency ablation instruments in people with Resistant Hypertension, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- Radiofrequency ablation instruments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhengzhou university People's Hospital
Zhengzhou, Henan
Chuanyu Gao, Dr, +86 13937165590, gaocy6802@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Resistant Hypertension
- Being tested
- Radiofrequency ablation instruments
- Keywords
- renal sympathetic denervation, resistant hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation instrumentsDevice
Renal Sympathetic Denervation from the adventitia of renal artery
| Study group | Role | What they receive |
|---|---|---|
| Renal sympathetic denervation from the adventitia | Experimental | Renal sympathetic denervation from the adventitia of renal artery and optimized medication regimen Receives: Device: Radiofrequency ablation instruments |
| optimized medication regimen | No intervention | optimized medication regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour average systolic blood pressure by ABPM in 6 months after discharge .
Measured: Baseline to 6 months
Secondary outcomes (7)
Change in types and doses of antihypertensive medications in 1,3,6,12 months after discharge.
Measured: 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
Measured: 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
Measured: Baseline to 1 months,3 months,12 months
Change in office systolic/diastolic blood pressure in 1,3,6,12 months after discharge
Measured: 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
Measured: Baseline to 1 months,3 months,6 months,12 months
renal function in 1,3,6,12 months after discharge
Measured: 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.
Measured: Baseline to 6 months,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start31 Oct 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chuanyu Gao, Dr., Principal investigator, Henan Provincial People's HospitalJiguang Huang, Dr., Principal investigator, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine;Shanghai Institute of Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758196
- Sponsor's protocol ID
- HenanICE201802
- Status last verified
- Mar 2020
- First submitted
- 27 Nov 2018
- Last updated
- 12 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Renal Sympathetic Denervation From the Adventitia on Resistant Hypertension.
- ClinicalTrials.gov ID
- NCT03758196
- Acronym / sponsor ID
- HenanICE201802
- Conditions
- Resistant Hypertension
- Keywords
- renal sympathetic denervation, resistant hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal sympathetic denervation from the adventitia | Experimental | Device: Radiofrequency ablation instrumentsRenal sympathetic denervation from the adventitia of renal artery and optimized medication regimen |
| optimized medication regimen | No intervention | –optimized medication regimen |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablation instrumentsRenal Sympathetic Denervation from the adventitia of renal artery | Device | Renal sympathetic denervation from the adventitia |
Primary outcome
Change in 24-hour average systolic blood pressure by ABPM in 6 months after discharge .
Time frame: Baseline to 6 months
7 secondary outcomes
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
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
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
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
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
renal function in 1,3,6,12 months after discharge
Time frame: 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.
Time frame: Baseline to 6 months,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chuanyu Gao, Dr. principal investigator
Henan Provincial People's Hospital
Jiguang Huang, Dr. principal investigator
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine;Shanghai Institute of Hypertension
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation instruments in people with Resistant Hypertension, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yahui Liu, Bachelor (+86 18317898825, 1182600873@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-hour average systolic blood pressure by ABPM in 6 months after discharge . (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.