Sympathetic Mapping/ Ablation of Renal Nerves Trial - Hemodialysis (SMART-HD)

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Hemodialysis
• Intervention / Treatment: Device: SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210003
      • Recruiting
      • Second Affiliated Hospital of Nanjing Medical University
      • Contact: Junwei Yang, MD, PhD; Phone Number: +8613655178822; Email: jwyang@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and non-pregnant female subjects, 18≤age≤70;
2. Hemodialysis vintage ≥ 6 months, three sessions per week, and Kt/v≥1.0;
3. History of hypertension is longer than 6 months;
4. Average 24-hour ABPM systolic blood pressure ≥130 mmHg, or daytime systolic blood pressure ≥135 mmHg, or nocturnal systolic blood pressure ≥120 mmHg;
5. Office SBP ≥150mmHg and ≤180mmHg;
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 BP ≥150 mmHg and ≤180 mmHg; 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 <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;
2. Average 24-hour systolic blood pressure (SBP) <135mmHg;
3. Pulse pressure > 80mmHg;
4. Using antihypertensive drugs, such as clonidine, minoxidil within 6 months;
5. Participated other clinical trials including both drug and medical device studies within 3 months enrollment;
6. Female with pregnant or lactating, or having plans for pregnancy within 1 year;
7. Patient with sleep apnea who needs chronic oxygen-breathing or mechanical ventilation support (for example, tracheostomy);
8. 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;
9. Any contradictions to conduct renal artery stimulation and ablation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Renal Sympathetic Denervation; Percutaneous renal denervation using the SyMapCath I™ Catheter and SYMPIONEER S1™ Stimulator/Generator.	Device: SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator; Radiofrequency ablation of renal arterial sympathetic nerves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	7 days after the procedure or at the time the patient is discharged from hospital
Reduction in office BP	Reduction in office BP at 1 month and 6 months after the treatment	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)	The control rates of office systolic blood pressure ( SBP<140mmHg) at 6 month after the treatment	6 month
Incidence of Intradialytic hypotension (IDH)	Decrease in systolic BP of ≥ 20 mm Hg during hemodialysis	1 month, 3 months, 6 months
All-cause death		1 month, 3 months, 6 months
AEs, SAEs, and severe cardio-cerebrovascular events		1 month, 3 months, 6 months
Rate of renal artery stenosis assessed by CT angiography	stenosis > 70%	6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2021
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (ACTUAL): May 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2020-12-HD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No