Status:
UNKNOWN
Sympathetic Mapping/ Ablation of Renal Nerves Trial - Hemodialysis
Lead Sponsor:
The Second Hospital of Nanjing Medical University
Collaborating Sponsors:
SyMap Medical (Suzhou), Ltd.
Conditions:
Hypertension
Hemodialysis
Eligibility:
All Genders
18-70 years
Phase:
NA
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, t...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04872114
Start Date
May 1 2021
End Date
December 31 2023
Last Update
May 4 2021
Active Locations (1)
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1
Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210003