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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012118
Receipt No. R000014166
Scientific Title Sleep pressure and disordered breathing in resistant hypertension and cardiovascular disease registry
Date of disclosure of the study information 2013/10/25
Last modified on 2019/03/29

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Basic information
Public title Sleep pressure and disordered breathing in resistant hypertension and cardiovascular disease registry
Acronym SPREAD Registry
Scientific Title Sleep pressure and disordered breathing in resistant hypertension and cardiovascular disease registry
Scientific Title:Acronym SPREAD 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 who meet the following criteria:
- Refractory hypertension
(Patients under treatment with 3 or more antihypertensive agents with office systolic blood pressure of 130 mmHg or higher, or diastolic blood pressure of 80 mmHg or higher)
- Cardiovascular disease
- Coronary artrey disease:
Patients who have a past history of coronary intervention or coronary artery bypass surgery, or diagnosed with coronary disease and receive the medical treatment.
- Heart failure:
Patients diagnosed with heart failure and receive the medical treatment.
- Sleep apnea syndrome (SAS):
Apnea hypopnea index (AHI) >5/hr by polysomnography, or suspected SAS and 3% oxygen desaturation index(ODI) 5 and higher, or current medical treatment for SAS.
- Peripheral artery disease:
Patients diagnosed by imaging and laboratory tests and treated by physician.
- Aorta dissection, aortic aneurysm:
Patients diagnosed by imaging and laboratory tests and treated by physician.
- Atrial fibrillation:
Patients diagnosed by imaging and laboratory tests and treated by electrocardiogram.

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 2000

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
Email 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
Email spread@jichi.ac.jp

Sponsor
Institute Jichi Medical University School of Medicine
Institute
Department

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
Email

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
鷲谷病院
国立国際医療研究センター病院
三菱三原病院
宗像市国保大島診療所
聖マリアンナ医科大学
九州大学病院
遠賀中間医師会おんが病院
昭和大学
長岡赤十字病院
大阪暁明館病院
聖路加国際病院
高橋医院
大阪府済生会富田林病院
宮下内科クリニック
天理よろづ相談所病院
沖縄県立中部病院
近内科クリニック
小竹町立病院
徳山医師会病院
田中内科医院
順天堂大学医学部附属 順天堂医院
京都府立医科大学大学院医学研究科
オムロンヘルスケア株式会社
オムロン株式会社

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 25 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
2012 Year 08 Month 20 Day
Date of IRB
2012 Year 08 Month 24 Day
Anticipated trial start date
2012 Year 08 Month 25 Day
Last follow-up date
2019 Year 03 Month 29 Day
Date of closure to data entry
2019 Year 03 Month 29 Day
Date trial data considered complete
Date analysis concluded
2019 Year 03 Month 29 Day

Other
Other related information None

Management information
Registered date
2013 Year 10 Month 25 Day
Last modified on
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014166

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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