Hypertrophic cardiomyopathy
Conditions
Interventions
None listed
Sponsors
National Hospital Organization Yokohama Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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) | — |
Countries
Japan
Contacts
Public ContactYoichi Ajiro
National Hospital Organization Yokohama Medical Center Cardiology
Outcome results
None listed