NCT06516068

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

August 11, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

June 28, 2024

Last Update Submit

July 15, 2025

Conditions

Obstructive Hypertrophic Cardiomyopathy

Outcome Measures

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

    After 12 weeks of HRS-1893 treatment

Secondary Outcomes (13)

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

    Baseline to Week 12

  • Change in LVEF

    Baseline to Week 12

  • Change in LVOT-VTI

    Baseline to Week 12

  • Change in LV-FS

    Baseline to Week 12

  • Change in LV-GLS

    Baseline to Week 12

  • +8 more secondary outcomes

Study Arms (1)

HRS-1893

EXPERIMENTAL
Drug: HRS-1893

Interventions

HRS-1893DRUG

HRS-1893

HRS-1893

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)

Beijing, Beijing Municipality, 100032, China

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2024

First Posted

July 23, 2024

Study Start

August 11, 2024

Primary Completion

November 18, 2024

Study Completion

August 1, 2025

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations

CN(1)