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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

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Abstract

Renal denervation (RDN) is proposed as a durable and patient compliance independent treatment for hypertension. However, 20–30% non-responder after RDN treatment weakened the therapeutic effect, which may be due to blind ablation. The renal nerve mapping/selective ablation system developed by SyMap Medical Ltd (Suzhou), China, has the function of mapping renal sympathetic/parasympathetic nerve sites and selectively removing renal sympathetic nerves and is expected to meet the urgent unmet clinical need of targeted RDN. The “Sympathetic Mapping/Ablation of Renal Nerves Trial” (SMART) is a prospective, multicenter, randomized, single-blinded, sham procedure-controlled trial, to evaluate the safety and efficacy of targeted renal sympathetic denervation in patients with essential and uncontrolled hypertension. The study is the first clinical registry trial using a targeted RDN for the treatment of uncontrolled hypertension; the dual-endpoint design can answer the question of how many antihypertensive drugs can be reduced in patients after RDN. The trial is registered on clinicaltrials.gov NCT02761811.

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Fig. 1

Adapted from Fudim M et al. Curr Hypertens Rep. 2018; 20: 37 [22], and Sakakura K et al. Journal of the American College of Cardiology 2014;64:635–643 [29]

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Abbreviations

ACEI:

Angiotensin-converting enzyme inhibition

AE:

Adverse event

ARB:

Angiotensin-II receptor blocker

BP:

Blood pressure

CCB:

Calcium channel blocker

CTA:

Computerized tomographic angiography

FAS:

Full analysis set

ITT:

Intention-to-treat

LC-M/M:

Liquid chromatography with tandem mass spectrometry

PPS:

Per-protocol set

RDN:

Renal denervation

RF:

Radiofrequency

SAE:

Serious adverse event

SS:

Safety set

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Funding

The study is sponsored by SyMap Medical Ltd (Suzhou), China.

Author information

Authors and Affiliations

  1. Division of Cardiology, Department of Medicine, College of Physician and Surgeons, Columbia University, New York, NY, 10032, USA

    Jie Wang

  2. Academy of Clinical and Translational Research Jiangsu Province, The First Affiliated Hospital With Nanjing Medical University, Nanjing, 210029, China

    Jie Wang & Yue Wang

  3. Department of Hypertension, Heart Center, Peking University People’s Hospital, Beijing, 100044, China

    Ningling Sun

  4. Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China

    Junbo Ge

  5. Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, 430060, China

    Hong Jiang

  6. Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, 400010, China

    Yuehui Yin

  7. Department of Cardiology, The First Affiliated Hospital With Nanjing Medical University, Nanjing, 210029, China

    Minglong Chen

  8. Peking University Clinical Research Institute, Beijing, 100191, China

    Chen Yao & Xiaoyan Yan

  9. Department of Biostatistics, Peking University First Hospital, Beijing, 100034, China

    Chen Yao

  10. Philadelphia, PA, USA

    Paul A. Sobotka

  11. Division of Cardiology, Peking University First Hospital, Beijing, 100034, China

    Yong Huo

Authors
  1. Jie Wang
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  10. Paul A. Sobotka
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  11. Yong Huo
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Corresponding authors

Correspondence to Jie Wang or Yong Huo.

Ethics declarations

Ethics Approval and Consent to Participate

The protocol was approved by the Ethics Committees of all participated hospitals. All procedures followed are in accordance with the ethical standards of the responsible committee on human experimentation and with the Helsinki Declaration of 1975, as revised in 2000. Informed consent is obtained from all patients previous to being included in the study.

Conflict of Interest

Jie Wang is a co-founder of SyMap Medical Ltd (Suzhou).

Sun N, Jiang H, Yin Y, Chen M, and Huo Y are consultants and received consultant honoraria from SyMap Medical Ltd (Suzhou). Sobotka PA is a consultant and receives consultant honoraria from SyMap Medical Ltd (Suzhou). Yan X received consultant honoraria from SyMap Medical Ltd (Suzhou).

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Editor-in-Chief Enrique Lara-Pezzi oversaw the review of this article.

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Wang, J., Sun, N., Ge, J. et al. 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. of Cardiovasc. Trans. Res. 16, 358–370 (2023). https://doi.org/10.1007/s12265-022-10307-z

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