Sympathetic Mapping/ Ablation of Renal Nerves Trial

NCT ID: NCT02761811

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2026-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Renal Sympathetic Denervation

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

Group Type: EXPERIMENTAL

SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator

Intervention Type: DEVICE

Radiofrequency ablation of renal arterial sympathetic nerves

Masked Procedure

Percutaneous renal artery angiography

Group Type: SHAM_COMPARATOR

SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator

Intervention Type: DEVICE

Radiofrequency ablation of renal arterial sympathetic nerves

Interventions

SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator

Radiofrequency ablation of renal arterial sympathetic nerves

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male and non-pregnant female subjects, 18≤age≤65

2. Essential hypertension

3. 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)

4. Average 24-hour ABPM systolic blood pressure ≥130mmHg, or ABPM systolic blood pressure during daytime ≥ 135mmHg, or ABPM systolic blood pressure during nighttime ≥ 120mmHg

5. History of hypertension is longer than 6 months

6. 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.

7. Patient is compliant and willing to complete clinical follow-up.

Exclusion Criteria

1. 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.

2. eGFR <45mL/min/1.73m2 (MDRD formula)

3. Hospitalized within one year due to hypertensive crisis

4. Average 24-hour systolic blood pressure <130mmHg and ABPM systolic blood pressure during daytime ≤ 135mmHg, and ABMP systolic blood pressure during nighttime ≤ 120mmHg

5. Pulse pressure >80mmHg

6. During running in period, using antihypertensive drugs other than standardized antihypertensive drugs

7. Participated other clinical trials including both drug and medical device studies within 3 months from current study

8. Female with pregnant or lactating, or having plans for pregnancy within 1 year

9. Patient with sleep apnea who needs chronic oxygen-breathing or mechanical ventilation support (for example, tracheostomy)

10. 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.

11. Any contradictions to conduct renal artery stimulation and ablation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tigermed Consulting Co., Ltd

INDUSTRY

Sponsor Role: collaborator

SyMap Medical (Suzhou), Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yong HUO, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

The Second Afflicted Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Norman Bethune International Peace Hospital

Shijiazhuang, Hebei, China

Hebei General Hospital

Shijiazhuang, Hebei, China

Daqing Oilfield General Hospital

Daqing, Heilongjiang, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Nanjing First Hospital

Nanjing, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Shanghai Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Taiyuan Central Hospital

Taiyuan, Shanxi, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin First Center Hospital

Tianjin, Tianjin Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 38756107 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36042146 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34269698 (View on PubMed)

Other Identifiers

2015-01

Identifier Type: -

Identifier Source: org_study_id