Clinical trial NCT01644604: Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension
Official title: The Clinical Study of Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uncontrolled Hypertension
Keywords: Hypertension
Vascular Diseases
Cardiovascular Diseases
Renal denervation
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2012-07-19
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Office Systolic Blood Pressure
timeFrame: Baseline to 6 months post-randomization
Secondary outcomes:
measure: Incidence of Major Adverse Events (MAE)
timeFrame: Baseline through 1 month post-randomization
Other outcomes:
Locations:
city: Hirosaki-shi
country: Japan
facility: Hirosaki University School of Medicine & Hospital
state: Aomori
city: Chiba-shi
country: Japan
facility: Chiba University Hospital
state: Chiba
city: Toon
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Asahikawa
country: Japan
facility: Asahikawa Medical University Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaido
city: Takarazuka
country: Japan
facility: Higashi Takarazuka Satoh Hospital
state: Hyogo
city: Tsukuba
country: Japan
facility: Tsukuba University Hospital
state: Ibaraki
city: Kamakura
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama Tobu Hospital
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Kumamoto University Hospital
state: Kumamoto
city: Sakyo-ku
country: Japan
facility: Kyoto University Hospital
state: Kyoto
city: Suita-shi
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Chiyoda-ku
country: Japan
facility: Mitsui Memorial Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
Study officials:
affiliation: New Oyama Municipal Hospital
name: Kazuyuki Shimada, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kario K, Bhatt DL, Brar S, Cohen SA, Fahy M, Bakris GL. Effect of Catheter-Based Renal Denervation on Morning and Nocturnal Blood Pressure: Insights From SYMPLICITY HTN-3 and SYMPLICITY HTN-Japan. Hypertension. 2015 Dec;66(6):1130-7. doi: 10.1161/HYPERTENSIONAHA.115.06260. Epub 2015 Oct 5.
citation: Kario K, Ogawa H, Okumura K, Okura T, Saito S, Ueno T, Haskin R, Negoita M, Shimada K; SYMPLICITY HTN-Japan Investigators. SYMPLICITY HTN-Japan - First Randomized Controlled Trial of Catheter-Based Renal Denervation in Asian Patients -. Circ J. 2015;79(6):1222-9. doi: 10.1253/circj.CJ-15-0150. Epub 2015 Apr 24.