UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019173 |
|---|---|
| Receipt number | R000022103 |
| Scientific Title | Effective Treatment for Elevated Nighttime-Home Blood Pressure in Patients with Hypertension (Prognostic Value of Nighttime Home Blood Pressure Reduction) |
| Date of disclosure of the study information | 2015/09/30 |
| Last modified on | 2023/10/06 09:33:33 |
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Basic information
Public title
Effective Treatment for Elevated Nighttime-Home Blood Pressure in Patients with Hypertension (Prognostic Value of Nighttime Home Blood Pressure Reduction)
Acronym
Treatment for Elevated Nighttime-Home Blood Pressure in Hypertensive Patients
Scientific Title
Effective Treatment for Elevated Nighttime-Home Blood Pressure in Patients with Hypertension (Prognostic Value of Nighttime Home Blood Pressure Reduction)
Scientific Title:Acronym
Treatment for Elevated Nighttime-Home Blood Pressure in Hypertensive Patients
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1)To investigate whether elevated nighttime-home blood pressure assessed by a home blood pressure device can be reduced by aggressive antihypertensive therapy in patients with hypertension.
(2)To evaluate the effect of reduction of nighttime-blood pressure by aggressive antihypertensive therapy on future cardiovascular events.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Proportion of patients whose elevated nighttime-systolic blood pressure (>or=120 mmHg) was reduced within the normal range (<120 mmHg) after 6-month agressive antihypertensive therapy.
(2)Effective combination, dose, and dosing time of antihypertensive agents.
Key secondary outcomes
(1)All fatal or nonfatal cardiovascular events (cerebravascular disease, coronary heart disease, death due to heart failure, and sudden death)
(2)New onset of left ventricular hypertrophy and atrial fibrillation
(3)New onset of diabetes mellitus
(4)New onset of proteinuria and impairement of kidney function
(5)Change of endothleial function assessed by flow-mediated vasodilation
(6)Adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Nighttime-blood pressure was measured using the home blood pressure device (HEM-7252G-HP; Omron, Kyoto, Japan) at 2:00, 3:00, 4:00, and 5 AM (4 points) for consecutive 7 days (at leaset more than 5 days). Nocturnal hypertension was defined as the average of all systolic blood pressure readings >or=120 mmHg. All patients with nocturnal hypertension receive aggressive antihypertensive therapy for 6 month to achieve target nighttime-home systolic blood pressure <120 mmHg. During treatment, nignttime-home blood pressure was measured at 2 month and 6 month just before hospital visiting for 5-7 days. If the nighttime-blood pressure was not normalized at 2 month, it should be measured at 4 month. Investigators are encouraged to adjust antihypertensive therapy at their discretion to achieve the target level of nightime-home systolic blood pressure every 1 month. The time of administration may be changd from morning to evening, using long-acting antihypertensive agents, the dose split into morning and evening or an additional dose taken in the evening or before going to bed.
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patietns with hypertension defined in the Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH2014) as a clinic systolic blood pressure of 140 mmHg or more and/or a diastolic blood pressure of 90 mmHg or more, or a home systolic blood pressure of 135 mmHg or more and/or a diastolic blood pressure of 85 mmHg or more who have been receiving antihypertensive therapy for more than 3 months.
(2)Patients who can be followed up for 5 years
(3)Patients who have given written informed consent to participate in the study
Key exclusion criteria
(1)Patients with severe valvular heart disease
(2)Patients with moderate or severe cardiac dysfunction (NYHA class III or IV)
(3)Patients with lethal arrhythmia after receiving implantable cardioverter defibrillator
(4)Patients with end-stage renal disease receiving dialysis
(5)Patients with malignant disease
(6)Patients receiving corticosteroid or immunosuppressive agent
(7)Patients with hepatic cirrhosis
(8)Pregnant, possible pregnant, or lactating women
(9)Patients who are considered not eligible for the study by the attending doctor due to other reasons
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Maruhashi |
Organization
Hiroshima University
Division name
Department of Regeneration and Medicine, Research Center for Radiation Genome Medicine, Research Institute for Radiation Biology and Medicine
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5540
55maruchin@gmail.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Maruhashi |
Organization
Hiroshima University
Division name
Department of Regeneration and Medicine, Research Center for Radiation Genome Medicine, Research Ins
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5540
Homepage URL
55maruchin@gmail.com
Sponsor or person
Institute
Department of Cardiovascular Medicine, Graduate School of Biomedical & Health Sciences, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University hospital IRB
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
Tel
082-257-5596
hugcp@hiroshima-u.ac.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
鈴川内科循環器科（広島県）、木下循環器・内科（広島県）、福永循環器・内科（広島県）、吉田内科循環器科（広島県）、みつだ循環器科内科（広島県）、中丸クリニック（広島県）、八田医院（広島県）、重信医院（広島県）、山本内科循環器科（広島県）、日下医院（広島県）、二宮内科（広島県）、梶山内科医院（広島県）、小田内科クリニック（広島県）、小園内科・循環器科（広島県）、よしだハートクリニック（広島県）、大岩内科（広島県）、松本内科循環器科医院（広島県）、かわごえ循環器内科（広島県）、しみずハート内科クリニック（広島県）、ＪＡ広島総合病院（広島県）、県立広島病院（広島県）、広島赤十字・原爆病院（広島県）、土谷総合病院（広島県）、呉共済病院（広島県）、済生会呉病院（広島県）、マツダ病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 30 | 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
514
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients were followed up.
Management information
Registered date
| 2015 | Year | 09 | Month | 30 | Day |
Last modified on
| 2023 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022103
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| Registered date | File name |
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