UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036612
Receipt number 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 2023/05/01 12:53:05

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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

Japan Clinical Medical Affairs

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

Japan Clinical Medical Affairs

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 or person

Institute

Medtronic Japan Co., Ltd

Institute

Department

Personal name



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

druginformation@mitsuihosp.or.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

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

257

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

Main results already published

Date of protocol fixation

2019 Year 02 Month 18 Day

Date of IRB

2019 Year 03 Month 25 Day

Anticipated trial start date

2019 Year 05 Month 15 Day

Last follow-up date

2026 Year 07 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

2023 Year 05 Month 01 Day



Link to view the page

Value
https://center6.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