Heart FailurePhase 3NCT06946095
Efficacy and Safety of Xinyue Capsule in the Treatment of Heart Failure With Preserved Ejection Fraction
A Phase 3 study testing Chinese patent medicine in people with Heart Failure, run by Beijing Anzhen Hospital.
Trial summary
The purpose of this study is to evaluate the effect of Xinyue Capsule in the improvement cardiac function and reduction the level of heart failure biomarker NT-proBNP in patients suffering from HF with an ejection fraction greater than or equal to 50%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Chinese patent medicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2025to 31 Oct 2027
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, and signed informed consent provided;
- Presence of symptoms such as dyspnea (including exertional dyspnea, paroxysmal nocturnal dyspnea, orthopnea), fatigue, poor appetite, and bilateral lower limb edema;
- Left Ventricular Ejection Fraction (LVEF) ≥ 50%, and meeting at least one of the following criteria:
- NT-proBNP ≥ 125 ng/L (sinus rhythm) or NT-proBNP ≥ 365 ng/L (atrial fibrillation);
Who cannot join
- Usage of Xinyue Capsule or other Chinese patent medicines/herbal remedies aimed at alleviating heart failure symptoms or biomarkers within the past 90 days;
- Known intolerance or significant allergic reaction to Xinyue Capsule;
- Occurrence of cardiovascular adverse events within the past 90 days;
- Acute decompensated heart failure, life-threatening arrhythmias, acute myocardial infarction, or cardiogenic shock;
- Heart failure secondary to pulmonary hypertension, anemia, thyroid disorders, chronic obstructive pulmonary disease, or musculoskeletal disorders;
- Presence of cardiac amyloidosis, storage diseases (hemochromatosis, glycogen storage disease), severe valvular heart disease, severe infections, malignancies, or significant hepatic or renal insufficiency.
About this study
Official title: Efficacy and Safety of Xinyue Capsule in the Treatment of Heart Failure With Preserved Ejection Fraction: A Clinical Study
The purpose of this study is to evaluate the effect of Xinyue Capsule in the improvement cardiac function and reduction the level of heart failure biomarker NT-proBNP in patients suffering from HF with an ejection fraction greater than or equal to 50%. Researchers will also collect information on how much the heart disease has impact on patient's lives, and how well Xinyue Capsule treatment is tolerated. The study plans to enroll 246 male and female patients of the age of 18 years and above suffering from heart failure with ejection fraction greater than or equal to 50%. Participants will take the study product as oral tablet with a dose 0.6 g Tid daily. Study duration will be up to 12 weeks.
- Conditions
- Heart Failure
- Being tested
- Chinese patent medicine
- Keywords
- Heart Failure with Preserved Ejection Fraction
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese patent medicineDrug
This study aims to investigate whether the addition of Xinyue Capsule to conventional Western medical therapy significantly improves cardiac function and reduces the level of heart failure biomarker NT-proBNP in patients with Heart Failure with Preserved Ejection Fraction (HFpEF).
| Study group | Role | What they receive |
|---|---|---|
| Chinese patent medicine | Experimental | Add Xinyue Capsules to the regular western medicine treatment. Receives: Drug: Chinese patent medicine |
| western medicine treatment | No intervention | only use the regular western medicine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
N-terminal pro-brain natriuretic peptide (NT-proBNP).
Measured: At baseline, Weeks 12
Secondary outcomes (9)
Mitral Annular e' Velocity Mitral Annular e' Velocity: Mitral Annular e' Velocity:
The mitral annular e' velocity is measured using tissue Doppler imaging (TDI) at the lateral or septal side of the mitral annulus during early diastole. It reflects the relaxation capacity of the left ventricle (LV). Reduced e' velocity is a key indicator of impaired LV diastolic function.
Measured: At baseline, Weeks 12
Six-minute walk distance.
A simple, non-invasive clinical test used to evaluate cardiopulmonary function and exercise tolerance. The patient walks as far as possible on a flat, hard surface for 6 minutes, with the total distance recorded. Longer 6MWD correlates with higher survival rates and lower hospitalization risks, especially in chronic heart or lung disease patients.
Measured: At baseline, Weeks 12
Minnesota Living with Heart Failure Questionnaire
The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a validated, patient-reported outcome measure specifically designed to assess the impact of heart failure on a patient's quality of life. It consists of 21 items that evaluate physical, emotional, and social limitations caused by heart failure over the preceding 4 weeks.
The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a validated, patient-reported outcome measure specifically designed to assess the impact of heart failure on a patient's quality of life. It consists of 21 items that evaluate physical, emotional, and social limitations caused by heart failure over the preceding 4 weeks.
The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a validated, patient-reported outcome measure specifically designed to assess the impact of heart failure on a patient's quality of life. The total score ranges from 0 to 105, with higher scores indicating poorer quality of life.
Measured: At baseline, Weeks 12
PHQ-9 score
The Patient Health Questionnaire-9 (PHQ-9) is a widely used screening tool for assessing the presence and severity of depressive symptoms. It consists of 9 questions, each corresponding to a symptom of major depressive disorder as defined by the DSM-5. Scores ≥10 typically indicate clinically significant depression requiring further evaluation. High scores (≥15) or suicidal ideation necessitate urgent referral to mental health professionals.
Measured: At baseline, Weeks 12
Average E/e' Ratio
The E/e' ratio is calculated by dividing the peak early diastolic mitral inflow velocity (E-wave, measured by pulsed-wave Doppler) by the average of the septal and lateral mitral annular e' velocities (from TDI). This ratio is used to estimate left ventricular filling pressure. An elevated E/e' ratio (typically >14) suggests increased diastolic filling pressure and possible heart failure with preserved ejection fraction (HFpEF).
Measured: At baseline, Weeks 12
Left Atrial Volume Index (LAVI)
The left atrial volume index is a measurement of left atrial size, calculated by dividing the left atrial volume (measured via the biplane method of disks on echocardiography) by the patient's body surface area (BSA). Elevated LAVI (>34 mL/m²) indicates left atrial enlargement, which is associated with chronic diastolic dysfunction, atrial fibrillation, and adverse cardiovascular outcomes.
Measured: At baseline, Weeks 12
Tricuspid Regurgitation Peak Velocity (TR Vmax)
The peak velocity of the tricuspid regurgitation jet is measured using continuous-wave Doppler. It reflects the pressure gradient between the right ventricle and right atrium during systole. Elevated TR Vmax (>3.4 m/s) is used to estimate pulmonary artery systolic pressure (using the simplified Bernoulli equation: 4V²) and may indicate pulmonary hypertension.
Measured: At baseline, Weeks 12
Left Ventricular Eccentricity Index (LVEI)
The left ventricular eccentricity index assesses the geometric shape of the LV in short-axis view at end-diastole. It is calculated as the ratio of the anteroposterior diameter to the septolateral diameter of the LV. An index >1.0 indicates LV eccentric remodeling, often seen in volume overload states (e.g., mitral/aortic regurgitation) or adaptive changes in dilated cardiomyopathy. In pressure overload (e.g., aortic stenosis), concentric remodeling typically predominates.
Measured: At baseline, Weeks 12
GAD-7 scores
The Generalized Anxiety Disorder-7 (GAD-7) is a validated screening tool used to assess the presence and severity of generalized anxiety symptoms. It contains 7 questions that align with DSM-5 criteria for generalized anxiety disorder (GAD). Scores ≥10: Refer for further evaluation (e.g., psychological assessment, diagnosis). Scores ≥15 or suicidal thoughts: Prioritize urgent mental health intervention. Monitor patients with chronic conditions (e.g., chronic pain, cancer) who may experience overlapping anxiety symptoms.
Measured: At baseline, Weeks 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start20 May 2025 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946095
- Sponsor's protocol ID
- drjihuang
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Xinyue Capsule in the Treatment of Heart Failure With Preserved Ejection Fraction: A Clinical Study
- ClinicalTrials.gov ID
- NCT06946095
- Acronym / sponsor ID
- drjihuang
- Conditions
- Heart Failure
- Keywords
- Heart Failure with Preserved Ejection Fraction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 27 Apr 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.
The purpose of this study is to evaluate the effect of Xinyue Capsule in the improvement cardiac function and reduction the level of heart failure biomarker NT-proBNP in patients suffering from HF with an ejection fraction greater than or equal to 50%. Researchers will also collect information on how much the heart disease has impact on patient's lives, and how well Xinyue Capsule treatment is tolerated. The study plans to enroll 246 male and female patients of the age of 18 years and above suffering from heart failure with ejection fraction greater than or equal to 50%. Participants will take the study product as oral tablet with a dose 0.6 g Tid daily. Study duration will be up to 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese patent medicine | Experimental | Drug: Chinese patent medicineAdd Xinyue Capsules to the regular western medicine treatment. |
| western medicine treatment | No intervention | –only use the regular western medicine treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years, and signed informed consent provided;
- Presence of symptoms such as dyspnea (including exertional dyspnea, paroxysmal nocturnal dyspnea, orthopnea), fatigue, poor appetite, and bilateral lower limb edema;
- Left Ventricular Ejection Fraction (LVEF) ≥ 50%, and meeting at least one of the following criteria:
Key exclusion criteria (6 listed)
- Usage of Xinyue Capsule or other Chinese patent medicines/herbal remedies aimed at alleviating heart failure symptoms or biomarkers within the past 90 days;
- Known intolerance or significant allergic reaction to Xinyue Capsule;
- Occurrence of cardiovascular adverse events within the past 90 days;
- Acute decompensated heart failure, life-threatening arrhythmias, acute myocardial infarction, or cardiogenic shock;
- Heart failure secondary to pulmonary hypertension, anemia, thyroid disorders, chronic obstructive pulmonary disease, or musculoskeletal disorders;
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 |
|---|---|---|
| Chinese patent medicineThis study aims to investigate whether the addition of Xinyue Capsule to conventional Western medical therapy significantly improves cardiac function and reduces the level of heart failure biomarker NT-proBNP in patients with Heart Failure with Preserved Ejection Fraction (HFpEF). | Drug | Chinese patent medicine |
Primary outcome
N-terminal pro-brain natriuretic peptide (NT-proBNP).
Time frame: At baseline, Weeks 12
9 secondary outcomes
Mitral Annular e' Velocity Mitral Annular e' Velocity: Mitral Annular e' Velocity:
Time frame: At baseline, Weeks 12
Six-minute walk distance.
Time frame: At baseline, Weeks 12
Minnesota Living with Heart Failure Questionnaire
Time frame: At baseline, Weeks 12
PHQ-9 score
Time frame: At baseline, Weeks 12
Average E/e' Ratio
Time frame: At baseline, Weeks 12
Left Atrial Volume Index (LAVI)
Time frame: At baseline, Weeks 12
Tricuspid Regurgitation Peak Velocity (TR Vmax)
Time frame: At baseline, Weeks 12
Left Ventricular Eccentricity Index (LVEI)
Time frame: At baseline, Weeks 12
GAD-7 scores
Time frame: At baseline, Weeks 12
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 27 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chinese patent medicine in people with Heart Failure, run by Beijing Anzhen Hospital.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N-terminal pro-brain natriuretic peptide (NT-proBNP). (time frame: At baseline, Weeks 12). 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 27 Apr 2025.