HRS-1893 for obstructive hypertrophic cardiomyopathy (Phase III)

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

This will test whether HRS-1893 tablets help adults 18–85 with obstructive hypertrophic cardiomyopathy (NYHA II–III) reduce left ventricular outflow obstruction and improve symptoms compared with placebo.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (industry)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07021976 on ClinicalTrials.gov

What this trial studies

This Phase III interventional trial compares oral HRS-1893 tablets to matching placebo in adults with obstructive hypertrophic cardiomyopathy who meet specific LVOT gradient and LVEF criteria. Eligible participants must have resting or Valsalva-provoked LVOT gradients above protocol thresholds, LVEF ≥60%, BMI <35, and NYHA class II–III symptoms. Participants are assigned to HRS-1893 or placebo and followed with regular clinic visits and echocardiography to monitor LVOT gradient, LVEF, symptoms, and adverse events. The primary focus is on clinical efficacy and safety in a multicenter setting centered at Fuwai Hospital in Beijing.

Who should consider this trial

Good fit: Adults aged 18–85 with obstructive hypertrophic cardiomyopathy, resting or Valsalva LVOT gradients meeting the protocol thresholds, LVEF ≥60%, NYHA class II–III, BMI <35, and able to give informed consent and attend study visits are ideal candidates.

Not a fit: Patients with nonobstructive HCM, significant valvular disease, known storage or infiltrative/genetic conditions causing hypertrophy, abnormal screening labs, or LVEF below 60% are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, HRS-1893 could lower LV outflow obstruction and symptoms, providing a new medication option that might reduce the need for invasive procedures.

How similar studies have performed: Earlier-phase clinical work of HRS-1893 was sufficient to advance to Phase III, indicating prior signs of safety or efficacy in smaller studies.

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.

Where this trial is running

Beijing, Beijing Municipality

• Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Yun Jin

Conditions: Obstructive Hypertrophic Cardiomyopathy