Unique ID issued by UMIN | UMIN000036612 |
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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 |
SPYRAL HTN-ON MED
SPYRAL HTN-ON MED
Global Clinical Study of Renal Denervation with the MDT-2115 multi-electrode renal denervation system in Patients with Uncontrolled Hypertension on Standard Medical Therapy
SPYRAL HTN-ON MED
Japan | North America | Australia |
Europe |
Hypertension
Cardiology |
Others
NO
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.
Safety,Efficacy
Confirmatory
Others
Phase III
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 ]
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)
Interventional
Cross-over
Randomized
Individual
Single blind -participants are blinded
Placebo
2
Treatment
Device,equipment |
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.
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.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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.
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.
340
1st name | Hitomi |
Middle name | |
Last name | Yoshida |
Medtronic Japan Co., Ltd.
Japan Clinical Medical Affairs
108-0075
1-2-70 Konan, Minato-ku, Tokyo
+81.3.6776.0056
hitomi.yoshida@medtronic.com
1st name | Hitomi |
Middle name | |
Last name | Yoshida |
Medtronic Japan Co., Ltd.
Japan Clinical Medical Affairs
108-0075
1-2-70 Konan, Minato-ku, Tokyo
+81.3.6776.0056
hitomi.yoshida@medtronic.com
Medtronic Japan Co., Ltd
Medtronic Japan Co., Ltd
Other
Mitsui Memorial Hospital IRB
Kanda-Izumi-cho 1, Chiyoda-ku, Tokyo
03-3862-9111
druginformation@mitsuihosp.or.jp
NO
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)
2019 | Year | 05 | Month | 07 | Day |
Published
257
Main results already published
2019 | Year | 02 | Month | 18 | Day |
2019 | Year | 03 | Month | 25 | Day |
2019 | Year | 05 | Month | 15 | Day |
2026 | Year | 07 | Month | 31 | Day |
2019 | Year | 04 | Month | 26 | Day |
2023 | Year | 05 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041709
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