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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036612
Receipt No. R000041709
Scientific Title Global Clinical Study of Renal Denervation with the MDT-2115 multi-electrode renal denervation system in Patients with Uncontrolled Hypertension on Standard Medical Therapy
Date of disclosure of the study information 2019/05/07
Last modified on 2019/04/26

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Basic information
Public title SPYRAL HTN-ON MED
Acronym SPYRAL HTN-ON MED
Scientific Title Global Clinical Study of Renal Denervation with the MDT-2115 multi-electrode renal denervation system in Patients with Uncontrolled Hypertension on Standard Medical Therapy
Scientific Title:Acronym SPYRAL HTN-ON MED
Region
Japan North America Australia
Europe

Condition
Condition Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to test the hypothesis that renal denervation is safe and reduces systolic blood pressure (SBP) in patients with uncontrolled hypertension on one, two, or three standard antihypertensive medications compared to a sham-controlled population.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Phase III

Assessment
Primary outcomes 1. Incidence of Major Adverse Events through one-month post -procedure (6 months for new renal artery stenosis)
2. Change in systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: From baseline to 6 months post-procedure ]

Key secondary outcomes Efficacy:
-Change in systolic blood pressure (SBP) from baseline (Screening Visit 2) as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) at 3, 6, 12, 24 and 36 months post-procedure
-Change in office systolic blood pressure from baseline (Screening Visit 2) at 1, 3, 6, 12, 24 and 36 months post-procedure
-Change in diastolic blood pressure from baseline (Screening Visit 2) as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) at 3, 6, 12, 24 and 36 months post-procedure
-Change in office diastolic blood pressure from baseline (Screening Visit 2) at 1, 3, 6, 12, 24 and 36 months post-procedure
-Incidence of achieving target office systolic blood pressure at 1, 3, 6, 12, 24 and 36 months post-procedure.

Safety:
-Acute/procedural safety at 1-month post-procedure
-Chronic Safety Secondary Endpoints at 3, 6, 12, 24 and 36 months post-procedure
-Summary of Health-related Quality of Life (HRQoL) analysis based on reporting measures using accepted QoL instruments (EQ5D)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Renal Denervation
(Renal Denervation, Renal angiography)
After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
Interventions/Control_2 Sham Procedure
(Renal angiography)
After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

(Crossover)
Control subjects may crossover to receive renal denervation therapy after completing their 6 month follow-up visit.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Individual has office systolic blood pressure (SBP) >= 150 mmHg and < 180 mmHg and a diastolic blood pressure (DBP) >= 90 mmHg when receiving a medication regimen of one, two, or three antihypertensive medication classes.
2. Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP >= 140 mmHg and < 170 mmHg.
Key exclusion criteria 1. Individual has renal artery anatomy that is ineligible for treatment.
2. Individual has estimated glomerular filtration rate (eGFR) of <45.
3. Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.
4. Individual has one or more episodes of orthostatic hypotension.
5. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
6. Individual has primary pulmonary hypertension.
7. Individual is pregnant, nursing or planning to become pregnant.
8. Individual has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment
9. Individual has one or more of the following conditions: stable or unstable angina within 3 months of enrollment, myocardial infarction within 3 months of enrollment; heart failure, cerebrovascular accident or transient ischemic attack, or atrial fibrillation at any time. Patients who received catheter or surgical treatment for atrial fibrillation and are in sinus rhythm are not excluded.
10. Individual works night shifts.
Target sample size 340

Research contact person
Name of lead principal investigator
1st name Hitomi
Middle name
Last name Yoshida
Organization Medtronic Japan Co., Ltd.
Division name Cardiovascular Group Clinical
Zip code 108-0075
Address 1-2-70 Konan, Minato-ku, Tokyo
TEL +81.3.6776.0056
Email hitomi.yoshida@medtronic.com

Public contact
Name of contact person
1st name Hitomi
Middle name
Last name Yoshida
Organization Medtronic Japan Co., Ltd.
Division name Cardiovascular Group Clinical
Zip code 108-0075
Address 1-2-70 Konan, Minato-ku, Tokyo
TEL +81.3.6776.0056
Homepage URL
Email hitomi.yoshida@medtronic.com

Sponsor
Institute Medtronic Japan Co., Ltd
Institute
Department

Funding Source
Organization Medtronic Japan Co., Ltd
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Mitsui Memorial Hospital IRB
Address Kanda-Izumi-cho 1, Chiyoda-ku, Tokyo
Tel 03-3862-9111
Email nagai.mmh@bridge.ocn.ne.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 自治医科大学附属病院(栃木県)、三井記念病院(東京都)、大阪府済生会中津病院(大阪府)、東宝塚さとう病院(兵庫県)、湘南鎌倉総合病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 02 Month 18 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 15 Day
Last follow-up date
2023 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 26 Day
Last modified on
2019 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041709

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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