A Phase III Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy

Launched by SHANDONG SUNCADIA MEDICINE CO., LTD. · Jun 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HRS-1893 for patients with a condition known as obstructive hypertrophic cardiomyopathy (oHCM). This heart condition causes the heart muscle to thicken, which can lead to problems with blood flow. The trial aims to evaluate how effective and safe HRS-1893 is for helping people with this condition. It is currently not yet recruiting participants, but when it begins, it will involve adults aged 18 to 85, regardless of gender, who have been diagnosed with oHCM and meet certain health criteria.

To be eligible for this study, participants should have specific measurements from heart tests showing how their heart functions, and they should be in a certain range of weight (BMI less than 35). Additionally, participants need to understand the study process and agree to follow the guidelines closely. Those with certain other heart conditions or significant health issues may not be able to participate. If you join the trial, you can expect to undergo regular evaluations and monitoring as part of the study to help determine how well HRS-1893 works for oHCM.

Gender

ALL

Eligibility criteria

• 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.