Obstructive Hypertrophic Cardiomyopathy
Conditions
Brief summary
The study is being conducted to evaluate the efficacy and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy.
Interventions
DRUGHRS-1893 Tablets
HRS-1893 tablets.
DRUGHRS-1893 Placebo Tablets
HRS-1893 placebo tablets.
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-85 years old, gender unlimited. 2. BMI\<35 kg/m2. 3. The diagnosis was obstructive hypertrophic cardiomyopathy. 4. Laboratory determination of echocardiography showed that Rest LVOT-G≥50 mmHg, or Rest LVOT-G≥30 mmHg and LVOT-G≥50 mmHg after Valsalva action. 5. Echocardiographic laboratory tests showed LVEF≥60%. 6. NYHA classification: Grade II - III. 7. Understand the study procedure and sign the informed consent in person, willing to strictly follow the clinical study protocol to complete the study.
Exclusion criteria
1. Known or suspected invasive, genetic or storage diseases (e.g. Noonan syndrome, Fabre's disease, amyloidosis) that cause cardiac hypertrophy (similar to oHCM). 2. Had a history of severe valvular heart disease. 3. Abnormal laboratory test results during screening, or any other clinically significant abnormal screening laboratory values, which are determined by the researcher to be unsuitable for inclusion. 4. Other circumstances where the researchers consider the subjects unsuitable to participate in this trial, such as physical or mental illnesses or conditions that may increase the risk of the trial, affect the subjects' compliance with the protocol, or affect the subjects' completion of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical response rate of treatment with HRS-1893. | After 24 weeks of HRS-1893 treatment. |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of major adverse cardiac events (cardiovascular death, cardiac arrest, non-fatal stroke, non-fatal myocardial infarction, hospitalization for cardiovascular events). | About 29 weeks. |
| Incidence and severity of any adverse events. | About 29 weeks. |
| The change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) from the baseline. | Week 12 and Week 24. |
Countries
China
Outcome results
None listed