Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension
HTN-J
The Clinical Study of Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension
1 other identifier
interventional
41
1 country
17
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2012
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedFirst Posted
Study publicly available on registry
July 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJuly 2, 2017
June 1, 2017
2.8 years
June 29, 2012
June 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Office Systolic Blood Pressure
Baseline to 6 months post-randomization
Secondary Outcomes (1)
Incidence of Major Adverse Events (MAE)
Baseline through 1 month post-randomization
Study Arms (2)
Renal denervation
EXPERIMENTALSubjects are treated with the renal denervation procedure after randomization and are maintained on baseline anti-hypertensive medications.
Control Group
NO INTERVENTIONSubjects are maintained on baseline anti-hypertensive medications
Interventions
A percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Hirosaki University School of Medicine & Hospital
Hirosaki-shi, Aomori, 036-8563, Japan
Chiba University Hospital
Chiba, Chiba, 260-8677, Japan
Ehime University Hospital
Tōon, Ehime, 791-0295, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011, Japan
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, 078-8510, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543, Japan
Higashi Takarazuka Satoh Hospital
Takarazuka, Hyōgo, 665-0873, Japan
Tsukuba University Hospital
Tsukuba, Ibaraki, 305-8576, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, 247-8533, Japan
Yokohama Tobu Hospital
Yokohama, Kanagawa, 230-0012, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, 860-8556, Japan
Kyoto University Hospital
Sakyo-ku, Kyoto, 606-8507, Japan
Osaka University Hospital
Suita-shi, Osaka, 565-0871, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, 329-0498, Japan
Mitsui Memorial Hospital
Chiyoda-ku, Tokyo, 101-8643, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666, Japan
Related Publications (2)
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.
PMID: 26558819DERIVEDKario 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.
PMID: 25912693DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Kazuyuki Shimada, MD
New Oyama Municipal Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2012
First Posted
July 19, 2012
Study Start
July 1, 2012
Primary Completion
April 1, 2015
Study Completion
June 1, 2017
Last Updated
July 2, 2017
Record last verified: 2017-06