Uncontrolled Hypertension
Conditions
Keywords
Hypertension, Vascular Diseases, Cardiovascular Diseases, Renal denervation
Brief summary
The objective of this study is to demonstrate that the MDT-2211 renal denervation system is a safe and effective treatment for uncontrolled hypertension subjects despite treatment with 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic, as best available antihypertensive therapy
Detailed description
The HTN-J study is a multi-center, prospective, unblinded, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the MDT-2211 renal denervation system - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.
Interventions
DEVICEMDT-2211 Renal Denervation System
A percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.
Sponsors
Medtronic Vascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Individual is ≥ 20 and ≤ 80 years old at time of randomization. * Individual is receiving a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 6 weeks prior to screening) that is expected to be maintained without changes for at least 6 months. * Individual has an office systolic blood pressure (SBP) of ≥ 160 mmHg based on an average of 3 blood pressure readings measured at both an initial screening visit and a confirmatory screening visit * Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.
Exclusion criteria
highlights: * Individual has an estimated glomerular filtration rate (eGFR) of \< 45 mL/min/1.73 m2 * Individual has an Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP \< 135 mmHg * Individual has type 1 diabetes mellitus * Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea. * Individual has primary pulmonary hypertension. * Individual is pregnant, nursing or planning to be pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Office Systolic Blood Pressure | Baseline to 6 months post-randomization |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Major Adverse Events (MAE) | Baseline through 1 month post-randomization |
Countries
Japan
Outcome results
None listed