-
1
Male and non-pregnant female subjects, 18 ≤ age ≤ 65
-
2
Essential hypertension
-
3
Office systolic blood pressure ≥150 mmHg and ≤180 mmHg; and resting heart rate ≥70 bpm without taking beta blocker (Resting heart rate does not taken into account if beta blocker is taken)
-
4
Average 24-h ABPM systolic blood pressure ≥130 mmHg, or ABPM systolic blood pressure during daytime ≥135 mmHg, or ABPM systolic blood pressure during nighttime ≥120 mmHg
-
5
History of hypertension is longer than 6 months
-
6
Patient with poor blood pressure control after 6 months of 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 systolic blood pressure ≥150 mmHg and ≤180 mmHg.
-
7
Patient is compliant and willing to complete clinical follow-up
|
-
1
Renal artery anatomy is unqualified including:
-
(1)
Diameter <4 mm or treatable length <25 mm,
-
(2)
Multiple renal arteries and the main renal artery supplies a fraction of the blood flow less than 75%,
-
(3)
Renal artery stenosis >50% or any renal artery aneurysms on either side,
-
(4)
History of renal artery PTA, including balloon angioplasty and stenting.
-
2
eGFR <45 mL/min/1.73 m2 (MDRD formula)
-
3
Hospitalized within one year due to hypertensive crisis
-
4
Average 24-h systolic blood pressure <130 mmHg and ABPM systolic blood pressure during daytime ≤135 mmHg, and ABPM systolic blood pressure during nighttime ≤120 mmHg
-
5
Pulse pressure ＞80 mmHg
-
6
During run in period, using antihypertensive drugs other than standardized antihypertensive drugs
-
7
Participated in other clinical trials including both drug and medical device studies within 3 months of current study
-
8
Female with pregnant or lactating, or having plans for pregnancy within 1 year
-
9
Patients with sleep apnea who need chronic oxygen or mechanical ventilation support (for example, tracheostomy) during sleep
-
10
Patients previously or currently suffering from following diseases:
-
(1)
Essential pulmonary arterial hypertension,
-
(2)
Type I diabetes,
-
(3)
Patients with severe cardiac valvular stenosis who have contradictions and cannot tolerant to significantly reduce blood pressure,
-
(4)
Within half year, patients had myocardial infraction, unstable angina, syncope or cerebrovascular accidents,
-
(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 6 months,
-
(8)
Alcohol abuse or unknown drug dependence history,
-
(9)
Neuroticisms such as depression or anxiety disorders.
-
11
non-compliant patients who are unable to follow the study protocol per physician's requests
-
12
Any contradictions to conduct renal artery stimulation and ablation
|
