UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020058 |
|---|---|
| Receipt number | R000023166 |
| Scientific Title | Sleep pressure in resistant hypertension registry |
| Date of disclosure of the study information | 2015/12/03 |
| Last modified on | 2019/03/29 10:47:11 |
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Basic information
Public title
Sleep pressure in resistant hypertension registry
Acronym
SPREAD 2nd Registry
Scientific Title
Sleep pressure in resistant hypertension registry
Scientific Title:Acronym
SPREAD 2nd Registry
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to study the relationship between frequency of sleep apnea syndrome and nocturnal hypertension in the patients of refractory hypertensive and cardiovascular disease by using the sphygmomanometers to measure the blood pressure surge due to the nighttime hypoxia. In addition, the aim of this study is to identify the high risk patients and provide them the optimal treatment from these results. The plan is to follow up the cases in this registry including of their baseline data to investigate the causal relationship between the frequency of sleep apnea syndrome and pathologies of blood pressure surge.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total mortality
Key secondary outcomes
Cardiovascular death, Sudden death, Ischemic heart disease, Cerebrovascular disease, De novo arteriosclerosis obliterans, Aortic dissection, heart failure that requires hospitalization, De novo diabetes, De novo atrial fibrillation, and Chronic hemodialysis
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients under treatment with antihypertensive agents with office systolic blood pressure of 140 mmHg or higher, or diastolic blood pressure of 90 mmHg or higher.
Key exclusion criteria
- Cerebral vascular disease within 6 months (except for asymptomatic or transient ischemic attack)
- Hemodialysis patients
- Having other severe diseases (cancer, connective tissue disease)
- Unwillingness to sign an informed consent.
- Patient him/herself or his/her family uses medical devices (e.g., pacemaker) which are affected by electric waves from mobile-phone.
- Patients considered as inappropriate to participate in this study by attending physicians.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuomi Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan.
TEL
0285-58-7344
kkario@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuomi Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan.
TEL
0285-58-7344
Homepage URL
spread@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Sleep and Circadian Cardiology, Jichi Medical University School of Medicine
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
Address
Tel
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 （栃木県）
鷲谷病院 （栃木県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 03 | 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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 29 | Day |
Other
Other related information
None
Management information
Registered date
| 2015 | Year | 12 | Month | 03 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023166
