Uncontrolled HypertensionHTN-JNCT01644604
Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension
A study testing MDT-2211 Renal Denervation System in people with Uncontrolled Hypertension, run by Medtronic Vascular at 17 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Uncontrolled Hypertension
- What is being tested?
- MDT-2211 Renal Denervation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 17 sitesJapan
- Study dates
- Jul 2012to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Japan17 sites
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, 078-8510
Chiba University Hospital
Chiba, Chiba, 260-8677
Mitsui Memorial Hospital
Chiyoda-ku, Tokyo, 101-8643
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Hirosaki University School of Medicine & Hospital
Hirosaki-shi, Aomori, 036-8563
Shonan Kamakura General Hospital
Kamakura, Kanagawa, 247-8533
Kumamoto University Hospital
Kumamoto, Kumamoto, 860-8556
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011
Kyoto University Hospital
Sakyo-ku, Kyoto, 606-8507
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543
Jichi Medical University Hospital
Shimotsuke, Tochigi, 329-0498
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666
Osaka University Hospital
Suita-shi, Osaka, 565-0871
Higashi Takarazuka Satoh Hospital
Takarazuka, Hyōgo, 665-0873
Ehime University Hospital
Tōon, Ehime, 791-0295
Tsukuba University Hospital
Tsukuba, Ibaraki, 305-8576
Yokohama Tobu Hospital
Yokohama, Kanagawa, 230-0012
About this study
Official title: The Clinical Study of Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension
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
Read the 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
- Being tested
- MDT-2211 Renal Denervation System
- Keywords
- Hypertension, Vascular Diseases, Cardiovascular Diseases, Renal denervation
- Medical subject headings
- Hypertension, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDT-2211 Renal Denervation SystemDevice
A percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.
| Study group | Role | What they receive |
|---|---|---|
| Renal denervation | Experimental | Subjects are treated with the renal denervation procedure after randomization and are maintained on baseline anti-hypertensive medications. Receives: Device: MDT-2211 Renal Denervation System |
| Control Group | No intervention | Subjects are maintained on baseline anti-hypertensive medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Office Systolic Blood Pressure
Measured: Baseline to 6 months post-randomization
Secondary outcomes (1)
Incidence of Major Adverse Events (MAE)
Measured: Baseline through 1 month post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2015
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kazuyuki Shimada, MD, Principal investigator, New Oyama Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644604
- Sponsor's protocol ID
- MDT2-11-07
- Acronym
- HTN-J
- Status last verified
- Jun 2017
- First submitted
- 29 Jun 2012
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26558819Kario 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.
PubMed 25912693
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension
- ClinicalTrials.gov ID
- NCT01644604
- Acronym / sponsor ID
- HTN-J / MDT2-11-07
- Conditions
- Uncontrolled Hypertension
- Keywords
- Hypertension, Vascular Diseases, Cardiovascular Diseases, Renal denervation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal denervation | Experimental | Device: MDT-2211 Renal Denervation SystemSubjects are treated with the renal denervation procedure after randomization and are maintained on baseline anti-hypertensive medications. |
| Control Group | No intervention | –Subjects are maintained on baseline anti-hypertensive medications |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDT-2211 Renal Denervation SystemA percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery. | Device | Renal denervation |
Primary outcome
Change in Office Systolic Blood Pressure
Time frame: Baseline to 6 months post-randomization
1 secondary outcome
Incidence of Major Adverse Events (MAE)
Time frame: Baseline through 1 month post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Derived from this study: PubMed 26558819Kario 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.
- Derived from this study: PubMed 25912693Kario 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazuyuki Shimada, MD principal investigator
New Oyama Municipal Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MDT-2211 Renal Denervation System in people with Uncontrolled Hypertension, run by Medtronic Vascular at 17 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Office Systolic Blood Pressure (time frame: Baseline to 6 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01644604, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.