A Phase II Clinical Trial of HRS-1893 in the Treatment of Heart Failure With Preserved Ejection Fraction
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorShandong Suncadia Medicine Co., Ltd.
About this trial
This study aims to evaluate the safety and tolerability of HRS-1893 in subjects with heart failure with preserved ejection fraction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 40 years at screening, regardless of gender;
Body mass index < 35 kg/m²;
Diagnosed with chronic heart failure before screening, and meeting relevant diagnostic criteria during the screening period: (1) Transthoracic echocardiography (TTE) at screening showing a resting left ventricular ejection fraction (LVEF) ≥ 60%; (2) Elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) during the screening period; (3) Echocardiography showing structural or functional abnormalities of the heart, etc.;
New York Heart Association (NYHA) classification of II or III at screening;
Disqualifiers
Previously diagnosed or found during screening with hypertrophic cardiomyopathy (HCM), or having infiltrative/genetic/storage diseases that cause heart failure with preserved ejection fraction (HFpEF)/myocardial hypertrophy (such as amyloidosis, Fabry disease, Noonan syndrome with left ventricular hypertrophy), or complete M protein or monoclonal light chain (such as κ or λ) detected in serum protein electrophoresis and serum immunofixation electrophoresis during screening (researchers may deem not applicable if amyloidosis/multiple myeloma are excluded);
Previously diagnosed or found during screening with hyperthyroidism;
At any time in their clinical history, previously experienced left ventricular systolic dysfunction (LVEF <45%);
History of syncope or sustained ventricular tachycardia within 6 months prior to screening;
Trial design
Design model
Parallel
Treatments tested in this trial
HRS-1893 Tablet
DrugHRS-1893 tablet.
HRS-1893 Tablet Placebo
DrugHRS-1893 tablet placebo.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: HRS-1893 Tablet GroupExperimental treatment 1 intervention
Group B: HRS-1893 Tablet Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events (AEs).
In heart failure patients with preserved ejection fraction after treatment with HRS-1893.
Time frame
Week 24.Secondary outcomes
1
Change from baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP).
In heart failure patients with preserved ejection fraction after treatment with HRS-1893.
Time frame
Week 12 and Week 24.2
Change from baseline in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS).
In heart failure patients with preserved ejection fraction after treatment with HRS-1893.
Time frame
Week 12 and Week 24.3
Proportion of heart failure patients with preserved ejection fraction with an improvement of ≥1 NYHA functional class from baseline.
In heart failure patients with preserved ejection fraction after treatment with HRS-1893.
Time frame
Week 12 and Week 24.4
Change from baseline in total distance walked during the six-minute walk test (6MWT).
In heart failure patients with preserved ejection fraction after treatment with HRS-1893.
Time frame
Week 12 and Week 24.Sponsors and contacts
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Source ClinicalTrials.gov