Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension

NCT ID: NCT01644604

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2017-06-30

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.

Conditions

Uncontrolled Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Renal denervation

Subjects are treated with the renal denervation procedure after randomization and are maintained on baseline anti-hypertensive medications.

Group Type: EXPERIMENTAL

MDT-2211 Renal Denervation System

Intervention Type: DEVICE

A percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.

Control Group

Subjects are maintained on baseline anti-hypertensive medications

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MDT-2211 Renal Denervation System

A percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.

Intervention Type: DEVICE

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

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Vascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kazuyuki Shimada, MD

Role: PRINCIPAL_INVESTIGATOR

New Oyama Municipal Hospital

Locations

Hirosaki University School of Medicine & Hospital

Hirosaki-shi, Aomori, Japan

Chiba University Hospital

Chiba, Chiba, Japan

Ehime University Hospital

Tōon, Ehime, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Kurume University Hospital

Kurume-shi, Fukuoka, Japan

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, Japan

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Higashi Takarazuka Satoh Hospital

Takarazuka, Hyōgo, Japan

Tsukuba University Hospital

Tsukuba, Ibaraki, Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Yokohama Tobu Hospital

Yokohama, Kanagawa, Japan

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

Kyoto University Hospital

Sakyo-ku, Kyoto, Japan

Osaka University Hospital

Suita-shi, Osaka, Japan

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Mitsui Memorial Hospital

Chiyoda-ku, Tokyo, Japan

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 26558819 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25912693 (View on PubMed)

Other Identifiers

MDT2-11-07

Identifier Type: -

Identifier Source: org_study_id