Heart Failure With Preserved Ejection FractionPhase 2NCT07269717
A Phase II Clinical Trial of HRS-1893 in the Treatment of Heart Failure With Preserved Ejection Fraction
A Phase 2 study testing HRS-1893 Tablet in people with Heart Failure With Preserved Ejection Fraction, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
This study aims to evaluate the safety and tolerability of HRS-1893 in subjects with heart failure with preserved ejection fraction. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- HRS-1893 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2026to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- KCCQ-CSS score between ≥25 and ≤75 at screening;
- Resting oxygen saturation >90% without supplemental oxygen at screening;
- Female participants of childbearing potential must have a negative serum pregnancy test before the first dose and must not be breastfeeding during the study. Female participants of childbearing potential and male participants whose partners are women of childbearing potential must agree to avoid donating sperm/eggs from the time of signing the informed consent until three months after the last dose of the study drug and comply with relevant contraceptive requirements;
- Understand the study procedures and methods, voluntarily participate in this trial, and provide written informed consent.
Who cannot join
- 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;
- Previously experienced cardiac arrest with resuscitation at any time or received ICD therapy for life-threatening ventricular arrhythmia within 6 months prior to screening;
- Previously diagnosed or found during screening with atrial fibrillation;
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- Coronary artery disease (stenosis >70% in one or more coronary arteries) or myocardial infarction: newly developed within 6 months prior to screening, or occurred more than 6 months prior without completed revascularization (such as percutaneous coronary intervention or coronary artery bypass grafting);
- Moderate to severe aortic stenosis, hemodynamically significant mitral stenosis, or severe mitral/tricuspid regurgitation at screening (as determined by the investigator);
- Severe chronic obstructive pulmonary disease (COPD) or other pulmonary diseases requiring home oxygen therapy, chronic nebulization/oral steroid treatment, or hospitalization due to pulmonary decompensation in the past 12 months;
- Acute respiratory infection at screening;
- Required intravenous diuretics, inotropes, vasodilators, or left ventricular assist device therapy for acute decompensated heart failure within 30 days prior to screening;
- Clinically significant history of malignancy within the past 5 years (excluding cancers that have been confirmed cured or in remission for ≥5 years, basal or squamous cell skin cancer that was radically excised within 5 years, carcinoma in situ of the cervix, and excised colon polyps);
- Electrocardiogram abnormalities posing safety risks at screening (as determined by the investigator, such as second-degree type II AV block, complete AV block, symptomatic ventricular arrhythmias, torsades de pointes, etc.);
- Any clinically significant abnormal screening laboratory values during screening deemed unsuitable for enrollment by the investigator;
- Positive result in any infectious disease screening during screening, including hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody (or AIDS virus antibody or P24 antigen);
- Inability to complete the six-minute walk test during screening (e.g., due to leg fractures, post-stroke mobility impairment);
- Patients who received β-blockers, diltiazem, or verapamil prior to screening but were not on a stable dose for more than 4 weeks before randomization, or are expected not to maintain the same medication regimen during the trial;
- Subjects who received heart failure medication treatment (diuretics, sodium-glucose co-transporter 2 inhibitors [SGLT2i], angiotensin receptor-neprilysin inhibitors [ARNI], mineralocorticoid receptor antagonists [MRA], angiotensin-converting enzyme inhibitors [ACEI], angiotensin II receptor blockers [ARB], glucagon-like peptide-1 [GLP-1] or GLP-1/glucose-dependent insulinotropic polypeptide [GIP]) prior to screening but have not been on a stable dose for more than 4 weeks before randomization, or are expected to be unable to maintain the same medication regimen during the trial;
- Subjects who used a myosin inhibitor within a period shorter than 5 half-lives before the trial drug administration;
- Subjects who participated in any drug or medical device clinical trial within 3 months prior to screening (participation in a clinical trial is defined as the subject having received the trial drug or medical device treatment);
- Other conditions deemed by the investigator that make the subject unsuitable for participation in the trial, such as conditions that may increase trial risk, affect the subject's protocol compliance, or impact the subject's ability to complete the trial due to physiological or psychological diseases or conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
Jingmin Zhou, +86-13601954136, zhou.jingmin@zs-hospital.sh.cn
Jingmin Zhou
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial on the Efficacy and Safety of HRS-1893 in the Treatment of Heart Failure With Preserved Ejection Fraction
This study aims to evaluate the safety and tolerability of HRS-1893 in subjects with heart failure with preserved ejection fraction.
- Being tested
- HRS-1893 Tablet, HRS-1893 Tablet Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1893 TabletDrug
HRS-1893 tablet.
HRS-1893 Tablet PlaceboDrug
HRS-1893 tablet placebo.
| Study group | Role | What they receive |
|---|---|---|
| HRS-1893 Tablet Group | Experimental | Not described Receives: Drug: HRS-1893 Tablet |
| HRS-1893 Tablet Placebo Group | Placebo comparator | Not described Receives: Drug: HRS-1893 Tablet Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs).
In heart failure patients with preserved ejection fraction after treatment with HRS-1893.
Measured: Week 24.
Secondary outcomes (6)
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.
Measured: Week 12 and Week 24.
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.
Measured: Week 12 and Week 24.
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.
Measured: Week 12 and Week 24.
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.
Measured: Week 12 and Week 24.
Change from baseline in resting left ventricular ejection fraction (LVEF).
In heart failure patients with preserved ejection fraction after treatment with HRS-1893.
Measured: Week 12 and Week 24.
Plasma concentration of HRS-1893.
In heart failure patients with preserved ejection fraction after treatment with HRS-1893.
Measured: Up to about 29 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start30 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269717
- Sponsor's protocol ID
- HRS-1893-203
- Status last verified
- May 2026
- First submitted
- 26 Nov 2025
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial on the Efficacy and Safety of HRS-1893 in the Treatment of Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT07269717
- Acronym / sponsor ID
- HRS-1893-203
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the safety and tolerability of HRS-1893 in subjects with heart failure with preserved ejection fraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-1893 Tablet Group | Experimental | Drug: HRS-1893 Tablet |
| HRS-1893 Tablet Placebo Group | Placebo comparator | Drug: HRS-1893 Tablet Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
- KCCQ-CSS score between ≥25 and ≤75 at screening;
Key exclusion criteria (21 listed)
- 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;
- Previously experienced cardiac arrest with resuscitation at any time or received ICD therapy for life-threatening ventricular arrhythmia within 6 months prior to screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-1893 TabletHRS-1893 tablet. | Drug | HRS-1893 Tablet Group |
| HRS-1893 Tablet PlaceboHRS-1893 tablet placebo. | Drug | HRS-1893 Tablet Placebo Group |
Primary outcome
Incidence and severity of adverse events (AEs).
Time frame: Week 24.
In heart failure patients with preserved ejection fraction after treatment with HRS-1893.
6 secondary outcomes
Change from baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP).
Time frame: Week 12 and Week 24.
Change from baseline in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS).
Time frame: Week 12 and Week 24.
Proportion of heart failure patients with preserved ejection fraction with an improvement of ≥1 NYHA functional class from baseline.
Time frame: Week 12 and Week 24.
Change from baseline in total distance walked during the six-minute walk test (6MWT).
Time frame: Week 12 and Week 24.
Change from baseline in resting left ventricular ejection fraction (LVEF).
Time frame: Week 12 and Week 24.
Plasma concentration of HRS-1893.
Time frame: Up to about 29 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-1893 Tablet in people with Heart Failure With Preserved Ejection Fraction, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianhong Lv (+86-0518-82342973, jianhong.lv.jl9@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs). (time frame: Week 24.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.