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NCT Number: NCT07021976

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

The study is being conducted to evaluate the efficacy and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Obstructive Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, 100032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HRS-1893 Tablets

Drug

HRS-1893 tablets.

HRS-1893 Placebo Tablets

Drug

HRS-1893 placebo tablets.

Primary outcomes

  1. The clinical response rate of treatment with HRS-1893.

    Time frame: After 24 weeks of HRS-1893 treatment.

Secondary outcomes

  1. 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.

  2. Incidence and severity of any adverse events.

    Time frame: About 29 weeks.

  3. The change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) from the baseline.

    Time frame: Week 12 and Week 24.

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2025
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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