UMIN-CTR Clinical Trial

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
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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	you617bacchus@gmail.com

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	you617bacchus@gmail.com

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	Suspended
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	2022 Year 03 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041047