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

This is an interventional treatment trial for Hypertension Read More

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.