HypertensionPhase 1/2NCT01390831
Renal Denervation in Patients With Uncontrolled Hypertension in Chinese
A Phase 1/2 study testing THERMOCOOL® Catheter in people with Hypertension, run by The Second People's Hospital of Chengdu.
Trial summary
The purpose of this study is to determine whether renal denervation is safe and effective in the treatment of Chinese patients with uncontrolled hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- THERMOCOOL® Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Jun 2015
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 18 years of age
- a systolic blood pressure of 160mmHg or more and/or a diastolic blood pressure of 90mmHg or more
- receiving and adhering to at least three full doses of appropriate antihypertensive drug regimen
- estimated glomerular filtration rate (eGFR) of ≥45mL/min
- agrees to have the study procedure(s) performed and additional procedures and evaluations
- is competent and willing to provide written, informed consent to participate in this clinical study
Who cannot join
- secondary hypertension
- renal arterial abnormalities
- has experienced MI, unstable angina pectoris, or CVA within 6 months
- has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI)
- requires respiratory support
- patients with sick sinus syndrome
- pregnant woman
- others
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to determine whether renal denervation is safe and effective in the treatment of Chinese patients with uncontrolled hypertension.
Read the detailed description
Prevalence of hypertension is increasing in China.While actually,the controlled rate of hypertension is relatively low,though numerous safe and effective pharmacological therapies are used in clinical practice.Studies confirmed that renal sympathetic nerves contributed to development and perpetuation of hypertension. Previous study has stated that renal denervation was effective and safe in patients with resistant hypertension, while little data is known in Chinese patients. We hypothesis that renal denervation is effective and safe in treatment of Chinese patients with uncontrolled hypertension. This trial plan to recruit 100 patients(Ablation group VS Control group = 1:1) with a follow up duration of 3 years.Patients in ablation group will receive percutaneous renal denervation combined with necessary antihypertension drugs and patients in control group will receive appropriate antihypertension drugs. We aim to explore the long term safety and validity of renal denervation in Chinese patients with uncontrolled hypertension.
- Conditions
- Hypertension
- Being tested
- THERMOCOOL® Catheter
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THERMOCOOL® CatheterDevice
Catheter-based renal denervation
| Study group | Role | What they receive |
|---|---|---|
| Catheter, Renal Denervation, Ablation | Experimental | Catheter-based renal denervation and maintenance of anti-hypertensive medications Receives: Device: THERMOCOOL® Catheter |
| anti-hypertensive medications | No intervention | Maintenance of anti-hypertensive medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Reduction
To confirm that renal denervation is safe, feasible and effective.
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 posted11 Jul 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second People's Hospital of Chengdu
- Sponsor type
- University, hospital or other
- Investigators
- Jian Xiong Liu, Principal investigator, The Second People's Hospital of Chengdu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390831
- Sponsor's protocol ID
- 2011SZ0118
- Status last verified
- Apr 2011
- First submitted
- 6 Jul 2011
- Last updated
- 11 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Denervation in Patients With Uncontrolled Hypertension in Chinese
- ClinicalTrials.gov ID
- NCT01390831
- Acronym / sponsor ID
- 2011SZ0118
- Conditions
- Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Second People's Hospital of ChengduUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 11 Jul 2011 (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.
The purpose of this study is to determine whether renal denervation is safe and effective in the treatment of Chinese patients with uncontrolled hypertension.
Detailed description
Prevalence of hypertension is increasing in China.While actually,the controlled rate of hypertension is relatively low,though numerous safe and effective pharmacological therapies are used in clinical practice.Studies confirmed that renal sympathetic nerves contributed to development and perpetuation of hypertension. Previous study has stated that renal denervation was effective and safe in patients with resistant hypertension, while little data is known in Chinese patients. We hypothesis that renal denervation is effective and safe in treatment of Chinese patients with uncontrolled hypertension. This trial plan to recruit 100 patients(Ablation group VS Control group = 1:1) with a follow up duration of 3 years.Patients in ablation group will receive percutaneous renal denervation combined with necessary antihypertension drugs and patients in control group will receive appropriate antihypertension drugs. We aim to explore the long term safety and validity of renal denervation in Chinese patients with uncontrolled hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter, Renal Denervation, Ablation | Experimental | Device: THERMOCOOL® CatheterCatheter-based renal denervation and maintenance of anti-hypertensive medications |
| anti-hypertensive medications | No intervention | –Maintenance of anti-hypertensive medications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >= 18 years of age
- a systolic blood pressure of 160mmHg or more and/or a diastolic blood pressure of 90mmHg or more
- receiving and adhering to at least three full doses of appropriate antihypertensive drug regimen
- estimated glomerular filtration rate (eGFR) of ≥45mL/min
- agrees to have the study procedure(s) performed and additional procedures and evaluations
Key exclusion criteria (8 listed)
- secondary hypertension
- renal arterial abnormalities
- has experienced MI, unstable angina pectoris, or CVA within 6 months
- has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI)
- requires respiratory support
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® CatheterCatheter-based renal denervation | Device | Catheter, Renal Denervation, Ablation |
Primary outcome
Blood Pressure Reduction
Time frame: one year
To confirm that renal denervation is safe, feasible and effective.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2011.
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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.
Jian Xiong Liu principal investigator
The Second People's Hospital of Chengdu
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing THERMOCOOL® Catheter in people with Hypertension, run by The Second People's Hospital of Chengdu.
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 8 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 11 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jian Xiong Liu, MD (862886621522-5205, steven.ljx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Reduction (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 11 Jul 2011.