HypertensionSMART-HDNCT04872114
Sympathetic Mapping/ Ablation of Renal Nerves Trial - Hemodialysis
A study testing SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator in people with Hypertension and Hemodialysis, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial summary
To evaluate the safety and efficacy of targeted renal sympathetic denervation using SyMapCath I™ in patients on hemodialysis with pharmacotherapy and uncontrolled hypertension for at least 6 months, then after standardized antihypertensive drug therapy (at least two drugs) for at least 28 days, office systolic blood… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension, Hemodialysis
- What is being tested?
- SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 31 Dec 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and non-pregnant female subjects, 18≤age≤70;
- Hemodialysis vintage ≥ 6 months, three sessions per week, and Kt/v≥1.0;
- History of hypertension is longer than 6 months;
- Average 24-hour ABPM systolic blood pressure ≥130 mmHg, or daytime systolic blood pressure ≥135 mmHg, or nocturnal systolic blood pressure ≥120 mmHg;
- Office SBP ≥150mmHg and ≤180mmHg;
- 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 BP ≥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 <20mm; (2) Renal artery stenosis >50% or any renal artery aneurysms on either side; (3) History of renal artery PTA, including balloon angioplasty and stenting;
- Average 24-hour systolic blood pressure (SBP) <135mmHg;
- Pulse pressure > 80mmHg;
- Using antihypertensive drugs, such as clonidine, minoxidil within 6 months;
- Participated other clinical trials including both drug and medical device studies within 3 months enrollment;
- Female with pregnant or lactating, or having plans for pregnancy within 1 year;
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- Patient with sleep apnea who needs chronic oxygen-breathing or mechanical ventilation support (for example, tracheostomy);
- Patients previously or currently suffering from following diseases: (1) Essential pulmonary arterial hypertension; (2) Type I diabetes; (3) Severe cardiac valvular stenosis with contradictions to significantly reduce blood pressure; (4) History of myocardial infraction (MI), unstable angina, syncope or cerebrovascular accidents within half year; (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 following 6 months; (8) alcohol abuse or unknown drug dependence history; (9) Neuroticisms such as depression or anxiety disorders; (10) Non-compliant patients unable to finish the research per physician's requests;
- Any contradictions to conduct renal artery stimulation and ablation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210003
Junwei Yang, MD, PhD, +8613655178822, jwyang@njmu.edu.cn
About this study
Official title: A Prospective, Single-center, Open-label, Self Controlled Case Series Trial of Renal Sympathetic Denervation Using SyMapCath I™ Catheter and SYMPIONEER S1™ Stimulator/Generator for the Treatment of Hypertension in Patients on Hemodialysis (SMART-HD Trial)
To evaluate the safety and efficacy of targeted renal sympathetic denervation using SyMapCath I™ in patients on hemodialysis with pharmacotherapy and uncontrolled hypertension for at least 6 months, then after standardized antihypertensive drug therapy (at least two drugs) for at least 28 days, office systolic blood pressure (BP) is still ≥ 150mmHg, ≤180mmHg.
Read the detailed description
This is a prospective, single-center, open-label, self controlled case series trial, in which patients on maintenance hemodialysis are diagnosed with essential hypertension with at least six months of 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 BP is still ≥ 150mmHg, ≤180mmHg, and meet the inclusion and exclusion criteria. These patients will conduct renal artery angiography followed by renal sympathetic nerve denvervation (30 patients). Patients with office BP which is not achieved ideal level (<140 mmHg) will titrate doses of classes of antihypertensive drugs according to a predefined standardized medication regimen until their office BP <140 mmHg.
Patients will be followed at 7 days after the procedure or at discharge from hospital, 1 month, 3 months and 6 months. Blood samples will be collected for drug tests to determine drug compliance of a patient.
Data collecting/management/statistical analysis and laboratory tests will be performed by independent, qualified organizations. Independent DSMB/CEC are formed and responsible for assessments of protocol deviations and natures of SAEs.
- Conditions
- Hypertension, Hemodialysis
- 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in office BP
Reduction in office BP at 3 month after the treatment
Measured: 3 month after the treatment
The composite index of anti-hypertensive drugs
The composite index of anti-hypertensive drugs at 6 months after the treatments
Measured: 6 months after the treatments
Secondary outcomes (10)
Reduction in office BP
Reduction in office BP at 1 month and 6 months after the treatment
Measured: 1 month, 6 months
Postoperative reduction in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) reduction in systolic, diastolic and mean arterial blood pressure
Measured: 1 month, 3 months, 6 months
The control rates of reduction in office systolic blood pressure (SBP) by 10mmHg or Ambulatory Systolic Blood Pressure (ASBP) by 5mmHg
Measured: 1 month, 3 months, 6 months
The control rates of office systolic blood pressure ( SBP<140mmHg)
The control rates of office systolic blood pressure ( SBP<140mmHg) at 6 month after the treatment
Measured: 6 month
Incidence of Intradialytic hypotension (IDH)
Decrease in systolic BP of ≥ 20 mm Hg during hemodialysis
Measured: 1 month, 3 months, 6 months
All-cause death
Measured: 1 month, 3 months, 6 months
AEs, SAEs, and severe cardio-cerebrovascular events
Measured: 1 month, 3 months, 6 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
Rate of renal artery stenosis assessed by CT angiography
stenosis > 70%
Measured: 6 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 2021
- Study start1 May 2021 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion31 Dec 2023 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- SyMap Medical (Suzhou), Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872114
- Sponsor's protocol ID
- 2020-12-HD
- Acronym
- SMART-HD
- Status last verified
- Apr 2021
- First submitted
- 29 Apr 2021
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Open-label, Self Controlled Case Series Trial of Renal Sympathetic Denervation Using SyMapCath I™ Catheter and SYMPIONEER S1™ Stimulator/Generator for the Treatment of Hypertension in Patients on Hemodialysis (SMART-HD Trial)
- ClinicalTrials.gov ID
- NCT04872114
- Acronym / sponsor ID
- SMART-HD / 2020-12-HD
- Conditions
- Hypertension, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- SyMap Medical (Suzhou), Ltd.
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 May 2021 (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.
To evaluate the safety and efficacy of targeted renal sympathetic denervation using SyMapCath I™ in patients on hemodialysis with pharmacotherapy and uncontrolled hypertension for at least 6 months, then after standardized antihypertensive drug therapy (at least two drugs) for at least 28 days, office systolic blood pressure (BP) is still ≥ 150mmHg, ≤180mmHg.
Detailed description
This is a prospective, single-center, open-label, self controlled case series trial, in which patients on maintenance hemodialysis are diagnosed with essential hypertension with at least six months of 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 BP is still ≥ 150mmHg, ≤180mmHg, and meet the inclusion and exclusion criteria. These patients will conduct renal artery angiography followed by renal sympathetic nerve denvervation (30 patients). Patients with office BP which is not achieved ideal level (<140 mmHg) will titrate doses of classes of antihypertensive drugs according to a predefined standardized medication regimen until their office BP <140 mmHg.
Patients will be followed at 7 days after the procedure or at discharge from hospital, 1 month, 3 months and 6 months. Blood samples will be collected for drug tests to determine drug compliance of a patient.
Data collecting/management/statistical analysis and laboratory tests will be performed 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and non-pregnant female subjects, 18≤age≤70;
- Hemodialysis vintage ≥ 6 months, three sessions per week, and Kt/v≥1.0;
- History of hypertension is longer than 6 months;
- Average 24-hour ABPM systolic blood pressure ≥130 mmHg, or daytime systolic blood pressure ≥135 mmHg, or nocturnal systolic blood pressure ≥120 mmHg;
- Office SBP ≥150mmHg and ≤180mmHg;
Key exclusion criteria (9 listed)
- Renal artery anatomy is unqualified including: (1) diameter <4mm or treatable length <20mm; (2) Renal artery stenosis >50% or any renal artery aneurysms on either side; (3) History of renal artery PTA, including balloon angioplasty and stenting;
- Average 24-hour systolic blood pressure (SBP) <135mmHg;
- Pulse pressure > 80mmHg;
- Using antihypertensive drugs, such as clonidine, minoxidil within 6 months;
- Participated other clinical trials including both drug and medical device studies within 3 months enrollment;
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 | Renal Sympathetic Denervation |
Primary outcome
Reduction in office BP
Time frame: 3 month after the treatment
Reduction in office BP at 3 month after the treatment
The composite index of anti-hypertensive drugs
Time frame: 6 months after the treatments
The composite index of anti-hypertensive drugs at 6 months after the treatments
10 secondary outcomes
Reduction in office BP
Time frame: 1 month, 6 months
Postoperative reduction in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) reduction in systolic, diastolic and mean arterial blood pressure
Time frame: 1 month, 3 months, 6 months
The control rates of reduction in office systolic blood pressure (SBP) by 10mmHg or Ambulatory Systolic Blood Pressure (ASBP) by 5mmHg
Time frame: 1 month, 3 months, 6 months
The control rates of office systolic blood pressure ( SBP<140mmHg)
Time frame: 6 month
Incidence of Intradialytic hypotension (IDH)
Time frame: 1 month, 3 months, 6 months
All-cause death
Time frame: 1 month, 3 months, 6 months
AEs, SAEs, and severe cardio-cerebrovascular events
Time frame: 1 month, 3 months, 6 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
Rate of renal artery stenosis assessed by CT angiography
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site 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 and Hemodialysis, run by The Second Hospital of Nanjing 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 9 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 4 May 2021. 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 Jie Wang, MD, PhD (+8613511604566, jay329329@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in office BP (time frame: 3 month 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?
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 4 May 2021.