Sympathetic Mapping/ Ablation of Renal Nerves Trial

NCT02761811 | Active Not Recruiting DMC

• 1 other identifier: 2015-01
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 15

Brief 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 standardized antihypertensive drug therapy (at least two drugs) for at least 28 days, office systolic blood pressure is still ≥ 150mmHg, ≤180mmHg.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• 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

  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

  6 months after the treatments

Secondary Outcomes (11)

• Reduction in average 24-hour Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure

  6 months

• Postoperative reduction in 24-hour ABPM in systolic, diastolic and mean arterial blood pressure

  discharge day or 7 days after procedure

• Reduction in office blood pressure

  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

  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

  during the procedure

Study Arms (2)

Renal Sympathetic Denervation

EXPERIMENTAL

Percutaneous renal denervation using the SyMapCath I™ Catheter and SYMPIONEER S1™ Stimulator/Generator.

Device: SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator

Masked Procedure

SHAM COMPARATOR

Percutaneous renal artery angiography

Device: SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator

Interventions

SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator DEVICE

Radiofrequency ablation of renal arterial sympathetic nerves

Masked Procedure; Renal Sympathetic Denervation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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:
• (1) 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.
• \. Any contradictions to conduct renal artery stimulation and ablation

Sponsors & Collaborators

• SyMap Medical (Suzhou), Ltd.: lead
• Tigermed Consulting Co., Ltd: collaborator

Study Sites (15)

Peking University First Hospital

Beijing, Beijing Municipality, 100038, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

The Second Afflicted Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

Location

Norman Bethune International Peace Hospital

Shijiazhuang, Hebei, 050000, China

Location

Hebei General Hospital

Shijiazhuang, Hebei, 050057, China

Location

Daqing Oilfield General Hospital

Daqing, Heilongjiang, 163458, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, 210000, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221004, China

Location

Shanghai Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Taiyuan Central Hospital

Taiyuan, Shanxi, 030009, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Tianjin First Center Hospital

Tianjin, Tianjin Municipality, 300192, China

Location

Related Publications (3)

• 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.

  PMID: 38756107 DERIVED

• Wang 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.

  PMID: 36042146 DERIVED

• Wang 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.

  PMID: 34269698 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Radionuclide Generators

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Radiation Equipment and Supplies; Equipment and Supplies

Study Officials

• Yong HUO, MD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 4, 2016
• Study Start: June 30, 2016
• Primary Completion: August 25, 2022
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 2, 2023

Record last verified: 2023-07

Locations

CN (15)