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Active, Not Recruiting

NCT Number: NCT06516068

A 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.

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 2

Primary location

Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)

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;
  • The diagnosis was obstructive hypertrophic cardiomyopathy.
  • Echocardiographic laboratory tests showed LVEF≥60%;
  • No previous left ventricular systolic dysfunction at any time (LVEF < 45%);
  • 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);
  • Previous left ventricular systolic dysfunction at any time in the clinical course (LVEF < 45%);
  • Previous history of aortic stenosis or subaortic fixed stenosis;

Treatment and study plan

HRS-1893

Drug

HRS-1893

Primary outcomes

  1. The subjects' left ventricular outflow tract pressure gradient (Valsalva LVOT-G) was assessed for changes from the baseline after performing the Valsalva maneuver

    Time frame: After 12 weeks of HRS-1893 treatment

Secondary outcomes

  1. Change in peak oxygen uptake (pVO2) and carbon dioxide ventilation equivalent (VE/VCO2)

    Time frame: Baseline to Week 12

  2. Change in LVEF

    Time frame: Baseline to Week 12

  3. Change in LVOT-VTI

    Time frame: Baseline to Week 12

  4. Change in LV-FS

    Time frame: Baseline to Week 12

  5. Change in LV-GLS

    Time frame: Baseline to Week 12

  6. Change in Rest LVOT-G

    Time frame: Baseline to Week 12

  7. Change in Valsalva LVOT-G

    Time frame: Baseline to Week 12

  8. Change in cardiac troponin

    Time frame: Baseline to Week 12

  9. Change in NT-proBNP

    Time frame: Baseline to Week 12

  10. Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)

    Time frame: Baseline to Week 12

  11. Proportion of participants with ≥ 1 class improvement in NYHA Functional Class

    Time frame: Baseline to Week 12

  12. Incidence and severity of any adverse events (AESI, SAE, TRAE, TEAE)

    Time frame: Through study completion, an average of 68 weeks

  13. plasma concentration of HRS-1893

    Time frame: Through study completion, an average of 68 weeks

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Open-label Phase II Clinical Study on the Efficacy and Safety of HRS-1893 in Obstructive Hypertrophic Cardiomyopathy Subjects.

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 23, 2024
Registry last updated
Jul 16, 2025

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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