HypertensionSMARTNCT02761811
Sympathetic Mapping/ Ablation of Renal Nerves Trial
A study testing SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator in people with Hypertension, run by SyMap Medical (Suzhou), Ltd. at 15 sites in China.
Trial summary
To evaluate the safety and efficacy of targeted renal sympathetic denervation using SyMapCath I® and SYMPIONEER S1® Stimulator/ Generator in patients with essential hypertension for at least 6 months of the disease history and pharmacotherapy, however, their blood pressure still cannot be controlled, then after… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 15 sitesChina
- Study dates
- 30 Jun 2016to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Male and non-pregnant female subjects, 18≤age≤65
- Essential hypertension
- Office systolic blood pressure ≥150mmHg and ≤180mmHg; and resting heart rate ≥70 bpm without taking beta blocker(Resting heart rate does not taken into account if beta blocker is taken)
- Average 24-hour ABPM systolic blood pressure ≥130mmHg, or ABPM systolic blood pressure during daytime ≥ 135mmHg, or ABPM systolic blood pressure during nighttime ≥ 120mmHg
- History of hypertension is longer than 6 months
- Patient with poor blood pressure control after 6 months of antihypertensive drug therapy, understands the purpose of this study, and is willing to participate and sign the Informed Consent; then the patient receives standard antihypertensive drug treatment (at least two drugs) for at least 28 days, drug compliance ≥80%, office systolic blood pressure ≥150 mmHg and ≤180 mmHg.
- Patient is compliant and willing to complete clinical follow-up.
Who cannot join
- Renal artery anatomy is unqualified including： (1) diameter <4mm or treatable length <25mm， (2) multiple renal arteries and the main renal artery supplies a fraction of the blood flow less than 75%, (3) renal artery stenosis >50% or any renal artery aneurysms on either side, (4) history of renal artery PTA, including balloon angioplasty and stenting.
- eGFR <45mL/min/1.73m2 (MDRD formula)
- Hospitalized within one year due to hypertensive crisis
- Average 24-hour systolic blood pressure <130mmHg and ABPM systolic blood pressure during daytime ≤ 135mmHg, and ABMP systolic blood pressure during nighttime ≤ 120mmHg
- Pulse pressure >80mmHg
- During running in period, using antihypertensive drugs other than standardized antihypertensive drugs
Show all 12Show fewer
- Participated other clinical trials including both drug and medical device studies within 3 months from current study
- Female with pregnant or lactating, or having plans for pregnancy within 1 year
- Patient with sleep apnea who needs chronic oxygen-breathing or mechanical ventilation support (for example, tracheostomy)
- Patients previously or currently suffering from following diseases:
- essential pulmonary arterial hypertension, (2) type I diabetes, (3) patients with severe cardiac valvular stenosis who have contradictions and cannot rolerant to significantly reduce blood pressure, (4) within half year, patients had myocardial infraction, unstable angina, syncope or cerebrovascular accidents, (5) history of primary aldosteronism, pheochromocytoma, aorta stenosis, hyperthyroidism or hyperparathyreosis, (6) any disease conditions interfering the measurement of blood pressure (for instance, severe peripheral artery diseases, abdominal artery aneurysm, hemorrhagic disorders such as thrombocytopenia, hemophilia and severe anemia), (7) plans to have surgery or cardiovascular interventions within 6 months, (8) alcohol abuse or unknown drug dependence history, (9) neuroticisms such as depression or anxiety disorders, (10) non-compliant patients who are unable to follow the study protocol per physician's requests.
- 11. Any contradictions to conduct renal artery stimulation and ablation
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100038
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
The Second Afflicted Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163458
Nanjing First Hospital
Nanjing, Jiangsu, 210000
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Shanghai Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
Norman Bethune International Peace Hospital
Shijiazhuang, Hebei, 050000
Hebei General Hospital
Shijiazhuang, Hebei, 050057
Taiyuan Central Hospital
Taiyuan, Shanxi, 030009
Tianjin First Center Hospital
Tianjin, Tianjin Municipality, 300192
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221004
About this study
Official title: A Prospective, Multicenter, Single Blind, Randomized and Sham Controlled Trial of Renal Sympathetic Denervation Using SyMapCath I™ Catheter and SYMPIONEER S1™ Stimulator/Generator for the Treatment of Hypertension (SMART Trial)
To evaluate the safety and efficacy of targeted renal sympathetic denervation using SyMapCath I® and SYMPIONEER S1® Stimulator/ Generator in patients with essential hypertension for at least 6 months of the disease history and pharmacotherapy, however, their blood pressure still cannot be controlled, then after standardized antihypertensive drug therapy (at least two drugs) for at least 28 days, office systolic blood pressure is still ≥ 150mmHg, ≤180mmHg.
Read the detailed description
This is a prospective, multicenter, single blind, randomized and sham controlled trial, in which patients are diagnosed with essential hypertension with at least six months of the disease history and pharmacotherapy however their blood pressure still cannot be controlled. The patients will be informed, consent and get into a screening process. During the screening period patients will receive a standardized antihypertensive drug treatment for at least 28 days and office systolic blood pressure is still ≥ 150mmHg, ≤180mmHg, and meet the inclusion and exclusion criteria. These patients will conduct renal artery angiography and be allocated to either renal sympathetic nerve denervation group or renal artery angiography group by a randomizing system in a 1:1 ratio (220 patients, 110 pairs). Patients with office systolic blood pressure which is not achieved ideal level (<140 mmHg) will titrate doses or classes of antihypertensive drugs according to a predefined standardized medication regimen until their office systolic blood pressure <140 mmHg, whereas in principle patients should follow the drug titration regimen, however, it is allowed to adjust antihypertensive medications per the real-world needs after 12 months.
Physicians who perform post-procedure patient management and physicians who perform renal denervation procedures are blinded to each other.
Patients will be followed at 7 days after the procedure or at discharge from hospital, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, 12months, 24months, 36 months, 48 months and 60 months for blood pressure measurements and antihypertensive medications. Urine samples will be collected for drug tests (LC-MS/MS) to determine drug compliance of a patient by an independent laboratory.
Data collecting/management/statistical analysis and laboratory tests will be done by independent, qualified organizations. Independent DSMB/CEC are formed and responsible for assessments of protocol deviations and natures of SAEs.
- Conditions
- Hypertension
- Being tested
- SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/GeneratorDevice
Radiofrequency ablation of renal arterial sympathetic nerves
| Study group | Role | What they receive |
|---|---|---|
| Renal Sympathetic Denervation | Experimental | Percutaneous renal denervation using the SyMapCath I™ Catheter and SYMPIONEER S1™ Stimulator/Generator. Receives: Device: SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator |
| Masked Procedure | Sham comparator | Percutaneous renal artery angiography Receives: Device: SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The control rate of office systolic blood pressure ( SBP<140mmHg)
The control rate of office systolic blood pressure ( SBP<140mmHg) at 6 months after the treatment
Measured: 6 months after the treatment
Change in the composite index of antihypertensive drugs to reach control of office systolic blood pressure (<140mmHg)
Change in the composite index of antihypertensive drugs to reach control of office systolic blood pressure (<140mmHg) at 6 months after the treatment
Measured: 6 months after the treatments
Secondary outcomes (11)
Reduction in average 24-hour Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure
Measured: 6 months
Postoperative reduction in 24-hour ABPM in systolic, diastolic and mean arterial blood pressure
Measured: discharge day or 7 days after procedure
Reduction in office blood pressure
Measured: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months, 24months, 36 months, 48 months and 60 months
Change in composite index of antihypertensive drugs
Measured: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months, 24months, 36 months, 48 months and 60 months
Success rate of the renal interventional therapy procedure
the renal denervation catheter can be engaged to the correct position in renal artery, successfully performed renal nerve ablation procedure and has no related complications such as renal arterial perforation
Measured: during the procedure
Success rate of clinical treatment
based on succeed performance of renal interventional therapy procedure , there are no the procedure-related SAE, such as acute infection and renal dysfunction
Measured: 7 days after the procedure or at the time the patient is discharged from hospital
All-cause death
Measured: 1 month, 3 months, 6 months, 9 months, 12 months, 24months, 36 months, 48 months and 60 months
Severe renal dysfunction
eGFR<15mL/min/m2 or renal function replacement therapy needed
Measured: 6 months, 24months, 36 months, 48 months and 60 months
Rate of renal artery stenosis assessed by CT angiography
(stenosis > 70% )
Measured: 6 months, 24months, 36 months, 48 months and 60 months
AEs, SAEs, and severe cardio-cerebrovascular events
Measured: 1 month, 3 months, 6 months, 9 months, 12months, 24months, 36 months, 48 months and 60 months
Reduction in 24-hour ABPM in systolic and diastolic arterial blood pressure
Measured: 24, 36, 48, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study start30 Jun 2016
- Primary completion25 Aug 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- SyMap Medical (Suzhou), Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Yong HUO, MD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761811
- Sponsor's protocol ID
- 2015-01
- Acronym
- SMART
- Status last verified
- Jul 2023
- First submitted
- 3 May 2016
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Our decision on whether to share the individual participant data depends on the opinions of the regulatory authorities in China, but so far the regulatory agencies have no clear instructions yet, thus we cannot make a decision at present.
Publications
Wang J, Yin Y, Lu C, Lu Z, Hu J, Wang Y, Ge J, Jiang H, Yao C, Yan X, Ma W, Qi X, Dang Y, Chen S, Zhu J, Wang D, Ding C, Wang W, Liu J, Wang Y, Li H, Pan Z, Cui K, Li C, Liang X, Chen W, Sobotka PA, Zhang J, Esler M, Sun N, Chen M, Huo Y. Efficacy and safety of sympathetic mapping and ablation of renal nerves for the treatment of hypertension (SMART): 6-month follow-up of a randomised, controlled trial. EClinicalMedicine. 2024 May 7;72:102626. doi: 10.1016/j.eclinm.2024.102626. eCollection 2024 Jun.
PubMed 38756107Wang J, Sun N, Ge J, Jiang H, Yin Y, Chen M, Wang Y, Yao C, Yan X, Sobotka PA, Huo Y. Rationale and Design of Sympathetic Mapping/Ablation of Renal Nerves Trial (SMART) for the Treatment of Hypertension: a Prospective, Multicenter, Single-Blind, Randomized and Sham Procedure-Controlled Study. J Cardiovasc Transl Res. 2023 Apr;16(2):358-370. doi: 10.1007/s12265-022-10307-z. Epub 2022 Aug 30.
PubMed 36042146Wang Y, Wang JW, Wang Y, Yang B, Yinghua Du A, Kong Z, Chen M, Wang J. Monitoring Antihypertensive Medication Adherence by Liquid Chromatography-Tandem Mass Spectrometry: Method Establishment and Clinical Application. J Cardiovasc Pharmacol. 2021 Oct 1;78(4):581-596. doi: 10.1097/FJC.0000000000001105.
PubMed 34269698
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single Blind, Randomized and Sham Controlled Trial of Renal Sympathetic Denervation Using SyMapCath I™ Catheter and SYMPIONEER S1™ Stimulator/Generator for the Treatment of Hypertension (SMART Trial)
- ClinicalTrials.gov ID
- NCT02761811
- Acronym / sponsor ID
- SMART / 2015-01
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (actual)
- Lead sponsor
- SyMap Medical (Suzhou), Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Study start
- 30 Jun 2016
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 May 2016 (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.
To evaluate the safety and efficacy of targeted renal sympathetic denervation using SyMapCath I® and SYMPIONEER S1® Stimulator/ Generator in patients with essential hypertension for at least 6 months of the disease history and pharmacotherapy, however, their blood pressure still cannot be controlled, then after standardized antihypertensive drug therapy (at least two drugs) for at least 28 days, office systolic blood pressure is still ≥ 150mmHg, ≤180mmHg.
Detailed description
This is a prospective, multicenter, single blind, randomized and sham controlled trial, in which patients are diagnosed with essential hypertension with at least six months of the disease history and pharmacotherapy however their blood pressure still cannot be controlled. The patients will be informed, consent and get into a screening process. During the screening period patients will receive a standardized antihypertensive drug treatment for at least 28 days and office systolic blood pressure is still ≥ 150mmHg, ≤180mmHg, and meet the inclusion and exclusion criteria. These patients will conduct renal artery angiography and be allocated to either renal sympathetic nerve denervation group or renal artery angiography group by a randomizing system in a 1:1 ratio (220 patients, 110 pairs). Patients with office systolic blood pressure which is not achieved ideal level (<140 mmHg) will titrate doses or classes of antihypertensive drugs according to a predefined standardized medication regimen until their office systolic blood pressure <140 mmHg, whereas in principle patients should follow the drug titration regimen, however, it is allowed to adjust antihypertensive medications per the real-world needs after 12 months.
Physicians who perform post-procedure patient management and physicians who perform renal denervation procedures are blinded to each other.
Patients will be followed at 7 days after the procedure or at discharge from hospital, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, 12months, 24months, 36 months, 48 months and 60 months for blood pressure measurements and antihypertensive medications. Urine samples will be collected for drug tests (LC-MS/MS) to determine drug compliance of a patient by an independent laboratory.
Data collecting/management/statistical analysis and laboratory tests will be done by independent, qualified organizations. Independent DSMB/CEC are formed and responsible for assessments of protocol deviations and natures of SAEs.
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 | Experimental | Device: SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/GeneratorPercutaneous renal denervation using the SyMapCath I™ Catheter and SYMPIONEER S1™ Stimulator/Generator. |
| Masked Procedure | Sham comparator | Device: SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/GeneratorPercutaneous renal artery angiography |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and non-pregnant female subjects, 18≤age≤65
- Essential hypertension
- Office systolic blood pressure ≥150mmHg and ≤180mmHg; and resting heart rate ≥70 bpm without taking beta blocker(Resting heart rate does not taken into account if beta blocker is taken)
- Average 24-hour ABPM systolic blood pressure ≥130mmHg, or ABPM systolic blood pressure during daytime ≥ 135mmHg, or ABPM systolic blood pressure during nighttime ≥ 120mmHg
- History of hypertension is longer than 6 months
Key exclusion criteria (12 listed)
- Renal artery anatomy is unqualified including： (1) diameter <4mm or treatable length <25mm， (2) multiple renal arteries and the main renal artery supplies a fraction of the blood flow less than 75%, (3) renal artery stenosis >50% or any renal artery aneurysms on either side, (4) history of renal artery PTA, including balloon angioplasty and stenting.
- eGFR <45mL/min/1.73m2 (MDRD formula)
- Hospitalized within one year due to hypertensive crisis
- Average 24-hour systolic blood pressure <130mmHg and ABPM systolic blood pressure during daytime ≤ 135mmHg, and ABMP systolic blood pressure during nighttime ≤ 120mmHg
- Pulse pressure >80mmHg
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 |
|---|---|---|
| SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/GeneratorRadiofrequency ablation of renal arterial sympathetic nerves | Device | Masked Procedure, Renal Sympathetic Denervation |
Primary outcome
The control rate of office systolic blood pressure ( SBP<140mmHg)
Time frame: 6 months after the treatment
The control rate of office systolic blood pressure ( SBP<140mmHg) at 6 months after the treatment
Change in the composite index of antihypertensive drugs to reach control of office systolic blood pressure (<140mmHg)
Time frame: 6 months after the treatments
Change in the composite index of antihypertensive drugs to reach control of office systolic blood pressure (<140mmHg) at 6 months after the treatment
11 secondary outcomes
Reduction in average 24-hour Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure
Time frame: 6 months
Postoperative reduction in 24-hour ABPM in systolic, diastolic and mean arterial blood pressure
Time frame: discharge day or 7 days after procedure
Reduction in office blood pressure
Time frame: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months, 24months, 36 months, 48 months and 60 months
Change in composite index of antihypertensive drugs
Time frame: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months, 24months, 36 months, 48 months and 60 months
Success rate of the renal interventional therapy procedure
Time frame: during the procedure
Success rate of clinical treatment
Time frame: 7 days after the procedure or at the time the patient is discharged from hospital
All-cause death
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months, 24months, 36 months, 48 months and 60 months
Severe renal dysfunction
Time frame: 6 months, 24months, 36 months, 48 months and 60 months
Rate of renal artery stenosis assessed by CT angiography
Time frame: 6 months, 24months, 36 months, 48 months and 60 months
AEs, SAEs, and severe cardio-cerebrovascular events
Time frame: 1 month, 3 months, 6 months, 9 months, 12months, 24months, 36 months, 48 months and 60 months
Reduction in 24-hour ABPM in systolic and diastolic arterial blood pressure
Time frame: 24, 36, 48, 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Derived from this study: PubMed 38756107Wang J, Yin Y, Lu C, Lu Z, Hu J, Wang Y, Ge J, Jiang H, Yao C, Yan X, Ma W, Qi X, Dang Y, Chen S, Zhu J, Wang D, Ding C, Wang W, Liu J, Wang Y, Li H, Pan Z, Cui K, Li C, Liang X, Chen W, Sobotka PA, Zhang J, Esler M, Sun N, Chen M, Huo Y. Efficacy and safety of sympathetic mapping and ablation of renal nerves for the treatment of hypertension (SMART): 6-month follow-up of a randomised, controlled trial. EClinicalMedicine. 2024 May 7;72:102626. doi: 10.1016/j.eclinm.2024.102626. eCollection 2024 Jun.
- Derived from this study: PubMed 36042146Wang J, Sun N, Ge J, Jiang H, Yin Y, Chen M, Wang Y, Yao C, Yan X, Sobotka PA, Huo Y. Rationale and Design of Sympathetic Mapping/Ablation of Renal Nerves Trial (SMART) for the Treatment of Hypertension: a Prospective, Multicenter, Single-Blind, Randomized and Sham Procedure-Controlled Study. J Cardiovasc Transl Res. 2023 Apr;16(2):358-370. doi: 10.1007/s12265-022-10307-z. Epub 2022 Aug 30.
- Derived from this study: PubMed 34269698Wang Y, Wang JW, Wang Y, Yang B, Yinghua Du A, Kong Z, Chen M, Wang J. Monitoring Antihypertensive Medication Adherence by Liquid Chromatography-Tandem Mass Spectrometry: Method Establishment and Clinical Application. J Cardiovasc Pharmacol. 2021 Oct 1;78(4):581-596. doi: 10.1097/FJC.0000000000001105.
- Individual participant dataSharing planned: Undecided. Our decision on whether to share the individual participant data depends on the opinions of the regulatory authorities in China, but so far the regulatory agencies have no clear instructions yet, thus we cannot make a decision at present.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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, MD principal investigator
Peking University First Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator in people with Hypertension, run by SyMap Medical (Suzhou), Ltd. at 15 sites 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 7 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
The control rate of office systolic blood pressure ( SBP<140mmHg) (time frame: 6 months after the treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02761811, which also lists 3 linked publications.
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 2 Aug 2023.