Hypertension, Resistant to Conventional TherapyNCT01848275
Full Length Versus Proximal Renal Arteries Ablation
A study testing Thermocool®Rcatheter in people with Hypertension, Resistant to Conventional Therapy, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
Catheter-based renal sympathetic modification has been documented to be effective option for blood pressure control in patients with resistant hypertension, but the safety is still concerned around worldwide. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Resistant to Conventional Therapy
- What is being tested?
- Thermocool®Rcatheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to Jun 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- office systolic blood pressure of 160 mm Hg or more,
- patients had to be on a stable drug regimen of at least 3 antihypertensive medications with no changes for 1 month before enrollment.
- Despite being treated with at least three antihypertensive drugs(including one diuretic), or confirmed intolerance to medications;
- ≥ 18 years old,;
- did not have any known secondary cause of hypertension;
- had a glomerular filtration rate estimated with the modification of diet in renal disease formula, of 45 ml/min/1.73m2 or more.
Who cannot join
- patients with type 1 diabetes,
- implanted pacemakers or implantable cardioverter defibrillators;
- pregnant women;
- haemodynamically significant valvular disease;
- patients with renovascular abnormalities(including mild to severe renal artery stenosis, especially caused by atherosclerosis, previous renal stenting or angioplasty, or known dual renal arteries, or diameter of renal artery identified by angiography less than 4 mm and/or length of renal artery less than 2 cm)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Efficacy Comparison of Two Renal Sympathetic Denervation Strategies ---- Full Length Versus Proximal Renal Arteries Ablation
Catheter-based renal sympathetic modification has been documented to be effective option for blood pressure control in patients with resistant hypertension, but the safety is still concerned around worldwide. Based on anatomic findings, blocking renal sympathetic nerves at proximity may be enough for successful renal sympathetic modifications. This study was designed to compare the efficacy and safety of full length versus proximal ablation of bilateral renal arteries.
Read the detailed description
After baseline assessment was completed, patients with resistant hypertension were enrolled, and randomly divided into two groups. This study is going to recruit 40 patients (group 1 VS group 2 = 1:1) with a follow-up duration of one year. Group 1 received ablation from distal to ostial of bilateral renal arteries, group 2 received ablation at proximal of bilateral renal arteries. RDN was performed with saline irrigated catheter. Office and ambulatory blood pressure was measured.
- Being tested
- Thermocool®Rcatheter
- Medical subject headings
- Hypertension Resistant to Conventional Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermocool®RcatheterDevice
The full length RDN was performed discretely from distal to proximal by point to point using Thermocool®Rcatheter
Thermocool®RcatheterDevice
The proximity renal denervation was performed discretely at 10-15 mm of proximal renal artery, using Thermocool®Rcatheter
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Group 1 received ablation from distal to ostial of bilateral renal arteries Receives: Device: Thermocool®Rcatheter |
| Group 2 | Experimental | group 2 received ablation at proximal of bilateral renal arteries Receives: Device: Thermocool®Rcatheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
office BP and Ambulatory blood pressure
Measured: one year
Secondary outcomes (1)
ablation-related complications
ablation-related complications such as pseudoaneurysm，renal artery injury
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startMar 2011
- Primary completionDec 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, Resistant to Conventional TherapyStudies 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
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848275
- Sponsor's protocol ID
- SWAN- RDN Strategy
- Status last verified
- Jul 2017
- First submitted
- 3 May 2013
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy Comparison of Two Renal Sympathetic Denervation Strategies ---- Full Length Versus Proximal Renal Arteries Ablation
- ClinicalTrials.gov ID
- NCT01848275
- Acronym / sponsor ID
- SWAN- RDN Strategy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 7 May 2013 (estimated)
- 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.
Catheter-based renal sympathetic modification has been documented to be effective option for blood pressure control in patients with resistant hypertension, but the safety is still concerned around worldwide. Based on anatomic findings, blocking renal sympathetic nerves at proximity may be enough for successful renal sympathetic modifications. This study was designed to compare the efficacy and safety of full length versus proximal ablation of bilateral renal arteries.
Detailed description
After baseline assessment was completed, patients with resistant hypertension were enrolled, and randomly divided into two groups. This study is going to recruit 40 patients (group 1 VS group 2 = 1:1) with a follow-up duration of one year. Group 1 received ablation from distal to ostial of bilateral renal arteries, group 2 received ablation at proximal of bilateral renal arteries. RDN was performed with saline irrigated catheter. Office and ambulatory blood pressure was measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: Thermocool®RcatheterGroup 1 received ablation from distal to ostial of bilateral renal arteries |
| Group 2 | Experimental | Device: Thermocool®Rcathetergroup 2 received ablation at proximal of bilateral renal arteries |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- office systolic blood pressure of 160 mm Hg or more,
- patients had to be on a stable drug regimen of at least 3 antihypertensive medications with no changes for 1 month before enrollment.
- Despite being treated with at least three antihypertensive drugs(including one diuretic), or confirmed intolerance to medications;
- ≥ 18 years old,;
- did not have any known secondary cause of hypertension;
Key exclusion criteria (5 listed)
- patients with type 1 diabetes,
- implanted pacemakers or implantable cardioverter defibrillators;
- pregnant women;
- haemodynamically significant valvular disease;
- patients with renovascular abnormalities(including mild to severe renal artery stenosis, especially caused by atherosclerosis, previous renal stenting or angioplasty, or known dual renal arteries, or diameter of renal artery identified by angiography less than 4 mm and/or length of renal artery less than 2 cm)
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 |
|---|---|---|
| Thermocool®RcatheterThe full length RDN was performed discretely from distal to proximal by point to point using Thermocool®Rcatheter | Device | Group 1 |
| Thermocool®RcatheterThe proximity renal denervation was performed discretely at 10-15 mm of proximal renal artery, using Thermocool®Rcatheter | Device | Group 2 |
Primary outcome
Blood pressure
Time frame: one year
office BP and Ambulatory blood pressure
1 secondary outcome
ablation-related complications
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermocool®Rcatheter in people with Hypertension, Resistant to Conventional Therapy, run by The Second Affiliated Hospital of Chongqing Medical University 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 17 Jul 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: one year). 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 17 Jul 2017.