Sympathetic Mapping/ Ablation of Renal Nerves Trial - Hemodialysis

NCT04872114 | Unknown DMC

• 1 other identifier: 2020-12-HD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 pressure (BP) is still ≥ 150mmHg, ≤180mmHg.

Conditions

Hypertension; Hemodialysis

Outcome Measures

Primary Outcomes (2)

• Reduction in office BP

  Reduction in office BP at 3 month after the treatment

  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

  6 months after the treatments

Secondary Outcomes (10)

• Reduction in office BP

  1 month, 6 months

• Postoperative reduction in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) reduction in systolic, diastolic and mean arterial blood pressure

  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

  1 month, 3 months, 6 months

• The control rates of office systolic blood pressure ( SBP<140mmHg)

  6 month

• Incidence of Intradialytic hypotension (IDH)

  1 month, 3 months, 6 months

Study Arms (1)

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

Interventions

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

Radiofrequency ablation of renal arterial sympathetic nerves

Renal Sympathetic Denervation

Eligibility Criteria

• Age: 18 Years - 70 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≤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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead
• SyMap Medical (Suzhou), Ltd.: collaborator

Study Sites (1)

Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210003, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Radionuclide Generators

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Radiation Equipment and Supplies; Equipment and Supplies

Central Study Contacts

Jie Wang, MD, PhD

CONTACT

+8613511604566; jay329329@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: December 31, 2023
• Last Updated: May 4, 2021

Record last verified: 2021-04

Locations

CN (1)