Last updated: March 21, 2023
Sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Diabetes And Hypertension
Stress
High Blood Pressure (Hypertension - Pediatric)
Treatment
N/AClinical Study ID
NCT05795829
LPCTP-2021-004
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age≥18 and≤80 years old, no gender limitation;
- Two or more antihypertensive drugs should be statically taken for at least 4 weeksbefore randomization and the prescribed dose should be ≥ 50% of the manufacturer'smaximum dose, angiotensin-converting enzyme inhibitor (ACEI) (or angiotensin-Ⅱreceptor antagonist (ARB)) and calcium channel blocker (CCB) (or thiazide diuretic)are required to be used in combination. Blood pressure meets the following conditions:
- office systolic blood pressure (SBP)≥150mmHg and<180mmHg; 2) office diastolic bloodpressure (DBP) ≥90mmHg;
- 24-hour ambulatory systolic blood pressure: ≥135 mmHg and <170 mmHg;
- A recorded history of essential hypertension;
- Understands the purpose of this study, and is willing to sign the Informed Consent andcomplete clinical follow-up.
Exclusion
Exclusion Criteria:
- Ineligible renal artery anatomy including : (1) multiple renal arteries, (2) mainrenal artery diameter <4mm or length <20mm, (3) renal artery stenosis > 50% in themain renal artery, (4) atherosclerosis of the renal artery, renal artery aneurysm,fibromuscular dysplasia or calcification, (5) pre-existing renal stent, (6) singlekidney
- Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2
- Type Ⅰ diabetes mellitus or poorly controlled type Ⅱ diabetes mellitus (defined asplasma Hb1Ac≥ 9.0% or 24-hour urinary protein quantification >1g/24h or proliferativeretinopathy)
- Postural hypotension
- Recent vascular events: Experienced acute myocardial infarction, unstable angina,syncope, or cerebrovascular accident within 3 months of the screening period
- Possible secondary hypertension
- Respiratory support: The individual requires long-term oxygen support or mechanicalventilation other than nocturnal respiratory support for sleep apnea
- Life expectancy <1 year
- Female who is pregnant, nursing, or planning to become pregnant
- Subjects who are currently enrolled in another clinical trial and have not completedtheir primary endpoint
- Subjects who are allergic to contrast medium
- Subjects who are unsuitable for the trial ,because of poor patient compliance or otherreasons judged by the investigator
Study Design
Total Participants: 10
Study Start date:
January 16, 2023
Estimated Completion Date:
February 29, 2024
Study Description
Connect with a study center
The Second Affiuated Hospital of Chongqing Medical University
Chongqing,
ChinaActive - Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin,
ChinaActive - Recruiting
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