Uncontrolled Hypertension Clinical Trial
Official title:
An Open-Label, Single Arm, Multicenter Feasibility Study to Evaluate the Safety of Catheter-Based Renal Denervation With the DENEX System in Patients With Uncontrolled Hypertension on Standard Medical Therapy
NCT number | NCT04248530 |
Other study ID # | DN_C101 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 30, 2016 |
Est. completion date | May 7, 2020 |
Verified date | May 2020 |
Source | Kalos Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is the multicenter pilot study to obtain an assessment of the safety of renal denervation in the patients with uncontrolled hypertension on standard medical therapy in Korea.
Status | Completed |
Enrollment | 16 |
Est. completion date | May 7, 2020 |
Est. primary completion date | July 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: 1. Individual is = 20 years of age at time of consent 2. Individual has office systolic blood pressure (SBP) of = 150 mmHg 3. Individual has daytime 24-hour Ambulatory Blood Pressure Monitoring (ABPM) SBP of = 140 mmHg 4. Individual maintains the following 3 antihypertensive medications: thiazide-type diuretic, calcium-channel blocker, and angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (for at least 6 weeks before the screening visit) that is expected to be maintained without changes for at least 6 months. Exclusion Criteria: 1. Main renal artery contains renal artery stenosis >50% 2. Individual has confirmed anatomical findings in kidneys or renal arteries through CT scan or angiogram 3. Undergone prior renal angioplasty 4. Main renal arterial vessel for each kidney <4 and >8 mm in diameter, or <20 mm length 5. Individual has an Estimated glomerular filtration rate <45 mL/min/1.73 m2 at screening visit 6. Individual has experienced myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 3 months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques 7. Individual has Hemodynamically or echocardiography significant valvular heart disease 8. Individual has secondary hypertension (pheochromocytoma, Cushing syndrome,coarctation of the aorta, renovascular hypertension, primary hyperaldosteronism, or other secondary hypertension) 9. Individual has documented primary pulmonary hypertension 10. Individual has orthostatic hypotension with symptom 11. Individual requires chronic oxygen support for sleep apnea 12. Individual is taking chronic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Only, Aspirin is permitted for cardiovascular disease prevention 13. Individual has Type 1 diabetes mellitus |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Pusan National University Hospital | Pusan | |
Korea, Republic of | Korea University Guro Hospital | Seoul | |
Korea, Republic of | Seoul St.Mary's Hospital | Seoul | |
Korea, Republic of | Severance Hospital | Seoul | |
Korea, Republic of | Uijeongbu St. Mary's Hospital | Uijeongbu |
Lead Sponsor | Collaborator |
---|---|
Kalos Medical |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of all adverse events | rate of major adverse events for 1 month after the treatment | From baseline to 1 month post-procedure | |
Secondary | Ambulatory SBP change at 3,6,12,24 months | Change in systolic blood pressure as measured by 24-hour ABPM at 3, 6, 12, 24 months post denervation | From baseline to 3, 6, 12, 24 months post-procedure | |
Secondary | Office SBP change at 1, 3, 6, 12, 18, 24 months | Change in office systolic blood pressure at 1, 3, 6, 12, 18, 24 months post denervation | From baseline to 1, 3, 6, 12, 18, 24 months post-procedure | |
Secondary | Percentage of decreased office SBP >10, 15, 20 mmHg | Percentage of subjects decreased office systolic blood pressure > 10 mmHg, 15 mmHg, 20 mmHg at 1, 3, 6, 12, 18, 24 months post denervation | From baseline to 1, 3, 6, 12, 18, 24 months post-procedure |
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