UMIN-CTR Clinical Trial

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
Last 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
1st 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