Primary HypertensionNCT03511313
Renal Denervation With Sterile Irrigated Deflectable Ablation Catheter Used in Renal Artery in Primary Hypertension
A study testing Renal denervation and Renal angiography in people with Primary Hypertension, run by Synaptic Medical Corporation at 1 site in China.
Trial summary
The purpose of this study is to assess the safety and efficacy of renal denervation with sterile irrigated deflectable ablation catheter used in renal artery in primary hypertension in China. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Hypertension
- What is being tested?
- Renal denervation and Renal angiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2018to Sep 2020
- 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
- Individual is ≥18 years and ≤65 years old.
- Primary hypertension.
- Screen criteria: Individual who received a stable anti-hypertensive medication regimen including 2 or more anti-hypertensive medications of different classes prior to screening, and at the initial screening visit, he has an office systolic blood pressure(SBP)≥ 150mmHg, and ≤180mmHg, is entering the screening period after writing the informed consent. Individual is receiving a 4week standard dose of amlodipine besylate (Norvasc) and Losartan Potassium and Hydrochlorothiazide tablets (HYZAAR®), and has a SBP≥150mmHg and<180mmHg at the second week after screening, and has an Ambulatory 24-hour daytime average systolic blood pressure monitoring ≥140mmHg and <170mmHg at the fourth week after screening.
Who cannot join
- Secondary hypertension.
- History of prior renal artery intervention including balloon angioplasty or stenting.
- Renal artery stenosis (≥50%) in either renal artery.
- Main renal arteries with <4mm, or >8mm in diameter.
- Main renal arteries with <20mm in length.
- Estimated glomerular filtration rate (eGFR) of <40 ml/(min•1.73m2).
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- History of Stroke or TIA within 6 months prior to screening period.
- History of Acute coronary syndrome within 6 months prior to screening period.
- Structural heart disease without receiving effective treatment; Coronary heart disease with β blockers; severe peripheral artery disease that affecting blood pressure measurement and other unqualified conditions evaluated by investigator.
- Heart failure (NYHA classification Ⅲ-Ⅳ).
- Coagulation disorders associated with significant bleeding tendency, and history of other blood system diseases.
- History of cancer.
- Type 1 diabetes mellitus; Type 2 diabetes mellitus with target organ injuring.
- Acute or severe systemic inflammatory response syndrome.
- Any other serious medical condition unqualified to participate in this study evaluated by investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Hanhua Wang, +86-010-66119205, jgbgs090101@126.com
WEI Ma, MD
About this study
Official title: A Prospective, Multi-centers, Randomized, Controlled Study of Assessing the Safety and Efficacy of Sterile Irrigated Deflectable Ablation Catheter Used in Renal Artery in Primary Hypertension
The purpose of this study is to assess the safety and efficacy of renal denervation with sterile irrigated deflectable ablation catheter used in renal artery in primary hypertension in China.
- Conditions
- Primary Hypertension
- Being tested
- Renal denervation, Renal angiography
- Keywords
- Primary Hypertension, Renal Denervation
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervationDevice
Also called Renal angiography
After a renal angiography according to standard procedures, subjects are treated with renal denervation (with sterile irrigated deflectable ablation catheter in renal artery), if without renal anatomic abnormality not detected by Renal CT/CTA.
Renal angiographyDiagnostic test
A renal angiography according to standard procedure.
| Study group | Role | What they receive |
|---|---|---|
| Renal denervation | Experimental | Renal angiography and renal denervation (with sterile irrigated deflectable ablation catheter in renal artery), and maintaining anti-hypertensive medications Receives: Device: Renal denervation; Diagnostic Test: Renal angiography |
| Renal angiography | Sham comparator | Renal angiography and maintaining anti-hypertensive medications Receives: Diagnostic Test: Renal angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daytime average systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring
Primary effective outcome measure
Measured: from baseline to 3 months post-procedure
Secondary outcomes (3)
Change in office systolic blood pressure
Secondary effective outcome measure
Measured: from baseline to 3 months post-procedure
Classes of anti-hypertensive medicine taken by participants
Secondary effective outcome measure
Measured: 6 months post-procedure
Incidence of achieving target office systolic blood pressure (office SBP<140mmHg)
Secondary effective outcome measure
Measured: from 3 months post-procedure to 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start11 Apr 2018
- Primary completionJun 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synaptic Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yong Huo, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511313
- Sponsor's protocol ID
- SNP-CT-1601
- Status last verified
- Apr 2018
- First submitted
- 26 Mar 2018
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-centers, Randomized, Controlled Study of Assessing the Safety and Efficacy of Sterile Irrigated Deflectable Ablation Catheter Used in Renal Artery in Primary Hypertension
- ClinicalTrials.gov ID
- NCT03511313
- Acronym / sponsor ID
- SNP-CT-1601
- Conditions
- Primary Hypertension
- Keywords
- Primary Hypertension, Renal Denervation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Synaptic Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 27 Apr 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.
The purpose of this study is to assess the safety and efficacy of renal denervation with sterile irrigated deflectable ablation catheter used in renal artery in primary hypertension in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal denervation | Experimental | Device: Renal denervation, Diagnostic Test: Renal angiographyRenal angiography and renal denervation (with sterile irrigated deflectable ablation catheter in renal artery), and maintaining anti-hypertensive medications |
| Renal angiography | Sham comparator | Diagnostic Test: Renal angiographyRenal angiography and maintaining anti-hypertensive medications |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individual is ≥18 years and ≤65 years old.
- Primary hypertension.
- Screen criteria: Individual who received a stable anti-hypertensive medication regimen including 2 or more anti-hypertensive medications of different classes prior to screening, and at the initial screening visit, he has an office systolic blood pressure(SBP)≥ 150mmHg, and ≤180mmHg, is entering the screening period after writing the informed consent. Individual is receiving a 4week standard dose of amlodipine besylate (Norvasc) and Losartan Potassium and Hydrochlorothiazide tablets (HYZAAR®), and has a SBP≥150mmHg and<180mmHg at the second week after screening, and has an Ambulatory 24-hour daytime average systolic blood pressure monitoring ≥140mmHg and <170mmHg at the fourth week after screening.
Key exclusion criteria (15 listed)
- Secondary hypertension.
- History of prior renal artery intervention including balloon angioplasty or stenting.
- Renal artery stenosis (≥50%) in either renal artery.
- Main renal arteries with <4mm, or >8mm in diameter.
- Main renal arteries with <20mm in length.
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 |
|---|---|---|
| Renal denervationAlso: Renal angiographyAfter a renal angiography according to standard procedures, subjects are treated with renal denervation (with sterile irrigated deflectable ablation catheter in renal artery), if without renal anatomic abnormality not detected by Renal CT/CTA. | Device | Renal denervation |
| Renal angiographyA renal angiography according to standard procedure. | Diagnostic test | Renal angiography, Renal denervation |
Primary outcome
Change in daytime average systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring
Time frame: from baseline to 3 months post-procedure
Primary effective outcome measure
3 secondary outcomes
Change in office systolic blood pressure
Time frame: from baseline to 3 months post-procedure
Classes of anti-hypertensive medicine taken by participants
Time frame: 6 months post-procedure
Incidence of achieving target office systolic blood pressure (office SBP<140mmHg)
Time frame: from 3 months post-procedure to 6 months post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
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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.
Yong Huo principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal denervation and Renal angiography in people with Primary Hypertension, run by Synaptic Medical Corporation 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 3 inclusion and 15 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 27 Apr 2018. 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. Some participants in this study may receive a placebo. 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 Jiayi Wang (+86-18511291205, jiayi.wang@synapticmed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daytime average systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring (time frame: from baseline to 3 months post-procedure). 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 27 Apr 2018.