UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036187 |
|---|---|
| Receipt number | 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 | 2022/03/29 16:16:51 |
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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
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
you617bacchus@gmail.com
Sponsor or person
Institute
National Hospital Organization Yokohama Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041047
