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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036187
Receipt No. R000041047
Scientific Title A study on the relevance between sleep apnea syndrome and heart failure in non-obstructive hypertrophic cardiomyopathy with left ventricular function maintained
Date of disclosure of the study information 2019/03/14
Last modified on 2019/05/07

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Basic information
Public title A study on the relevance between sleep apnea syndrome and heart failure in non-obstructive hypertrophic cardiomyopathy with left ventricular function maintained
Acronym NHOC-HCM
Scientific Title A study on the relevance between sleep apnea syndrome and heart failure in non-obstructive hypertrophic cardiomyopathy with left ventricular function maintained
Scientific Title:Acronym NHOC-HCM
Region
Japan

Condition
Condition Hypertrophic cardiomyopathy
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the relevance of heart failure and sleep disorder breathing (SDB) in non-obstructive hypertrophic cardiomyopathy (HCM) where left ventricular function is preserved
Basic objectives2 Others
Basic objectives -Others To compare the incidence of heart failure hospitalization in non-obstructive HCM with preserved left ventricular function in 3 groups: no SDB group, SDB with continuous positive airway pressure (CPAP) treatment group, SDB without CPAP treatment group including CPAP discontinuation group
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To compare the incidence of heart failure hospitalization in non-obstructive HCM with preserved left ventricular function in 3 groups: no SDB group, SDB with CPAP treatment group, SDB without CPAP treatment group including CPAP discontinuation group
Key secondary outcomes - SDB (defined as apnea hypopnea index(AHI) >= 5.0/hour) complication rate in non-obstructive HCM with preserved left ventricular function
- Severe SAS (defined as AHI >= 20.0/hour) complication rate in non-obstructive HCM with preserved left ventricular function
- Relevance between SDB or severe SAS and biomarker (BNP, TGF beta 1)
- Biomarker change before and after CPAP treatment (BNP, TGF beta 1)
- Comparison of background factors between SDB presence-absence and SAS severity
- Relevance between heart failure hospitalization and background factors
- Relevance with prognosis by biomarker (BNP, TGF beta 1) at registration
- Relevance to prognosis by biomarker at 1 year (BNP, TGF beta 1)
- Relevance of prognosis between CPAP treatment continuation case and dropout case in severe SAS (AHI >= 20/h)

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 (1) Diagnosed with HCM according to "the Guidelines for Diagnosis and Treatment of Patients with Hypertrophic Cardiomyopathy (2012 revised version)" by the Japanese Circulation Society: confirmed explanatory asymmetric left ventricular hypertrophy by pressure overload that is detected by imaging modalities centered on echocardiography
(2) Without SDB confirmed
(3) Over 20 years of age at the time of consent
(4) Provided written consent by their free will or the representatives (an individual who exercises parental rights over a subject, the subject's spouse or guardian, or any other person who is considered to be such a representative)
Key exclusion criteria (1) Having treated by oral appliance (OA), CPAP, Adaptive Servo-Ventilation (ASV), Bi-level positive airway pressure (BiPAP), and surgical treatment at the time of registration
(2)Diagnosed with secondary myocardial hypertrophy such as Fabry disease
(3) Hospitalized for decompensated heart failure at registration
(4)Undergoing ventricular resynchronization therapy (Cardiac Resynchronization Therapy: CRT)
(5) With a history of open heart surgery such as artificial valve replacement surgery accompanying pericardiotomy
(6)With left ventricular outflow tract gradient >= 30 mmHg
(7) With dilated hypertrophic cardiomyopathy (defined as with left ventricular ejection fraction <40%)
(8)With malignant tumor complications
(9)Judged by the attending physician as inappropriate to participate in this study due to chronic hepatitis or cirrhosis
(10) Same as above, except due to pulmonary fibrosis accompanied by elevation of either KL-6, SP-D or SP-A
(11) Same as above, except due to rheumatoid arthritis
(12)Judged by the principal investigator or sub-investigators as inappropriate for participation in this study
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Yoichi
Middle name
Last name Ajiro
Organization National Hospital Organization Yokohama Medical Center
Division name Cardiology
Zip code 245-8575
Address 3-60-2, Harajyuku, Totsuka-ku, Yokohama-shi, Kanagawa
TEL 045-851-2621
Email ajiro-yoichi.rb@mail.hosp.go.jp

Public contact
Name of contact person
1st name Yoichi
Middle name
Last name Ajiro
Organization National Hospital Organization Yokohama Medical Center
Division name Cardiology
Zip code 245-8575
Address 3-60-2, Harajyuku, Totsuka-ku, Yokohama-shi, Kanagawa
TEL 045-851-2621
Homepage URL
Email ajiro-yoichi.rb@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization Yokohama Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Clinical Research Central Ethics Review Committee
Address 2-5-21,Higashigaoka,Meguro-ku,Tokyo
Tel 03-5712-5050
Email kenkyu2004@hosp.go.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

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 14 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 Open public recruiting
Date of protocol fixation
2019 Year 01 Month 25 Day
Date of IRB
2019 Year 01 Month 25 Day
Anticipated trial start date
2019 Year 03 Month 14 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: prospective cohort study
Recruit method: all patients who meet the inclusion criteria in patients who visited this study facility during the registration period.
Registration period: approval of the National Hospital Organization Clinical Research Center Ethics Review Committee (hereinafter referred to as the "Central Ethics Review Committee") until March 31, 2021

Management information
Registered date
2019 Year 03 Month 13 Day
Last modified on
2019 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041047

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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