Recruiting NCT07021976
A Phase III Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-1893 Tablets, HRS-1893 Placebo Tablets.
- Who it may be relevant to
- Registry conditions: Obstructive Hypertrophic Cardiomyopathy. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicentre, Randomized, Double-blind, Placebo-parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of HRS-1893 Tablets in the Treatment of Obstructive Hypertrophic Cardiomyopathy
Overview
The study is being conducted to evaluate the efficacy and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy.
Interventions
- Drug HRS-1893 Tablets
HRS-1893 tablets. - Drug HRS-1893 Placebo Tablets
HRS-1893 placebo tablets.
Primary outcome measures
- The clinical response rate of treatment with HRS-1893. [Time frame: After 24 weeks of HRS-1893 treatment.]
Secondary outcome measures (3)
- The incidence of major adverse cardiac events (cardiovascular death, cardiac arrest, non-fatal stroke, non-fatal myocardial infarction, hospitalization for cardiovascular events). [Time frame: About 29 weeks.]
- Incidence and severity of any adverse events. [Time frame: About 29 weeks.]
- The change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) from the baseline. [Time frame: Week 12 and Week 24.]
Eligibility criteria
Inclusion criteria
- Age 18-85 years old, gender unlimited.
- BMI<35 kg/m2.
- The diagnosis was obstructive hypertrophic cardiomyopathy.
- 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.
- Echocardiographic laboratory tests showed LVEF≥60%.
- NYHA classification: Grade II - III.
- 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
- Known or suspected invasive, genetic or storage diseases (e.g. Noonan syndrome, Fabre's disease, amyloidosis) that cause cardiac hypertrophy (similar to oHCM).
- Had a history of severe valvular heart disease.
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College — Beijing
Identifiers
NCT: NCT07021976 · HRS-1893-301