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Heart Failure with Preserved Ejection FractionNCT06377761

Study on Heart Failure with Preserved Ejection Fraction with Qishen Granules

A study testing Qishen Granules in people with Heart Failure with Preserved Ejection Fraction, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

With the cardiopulmonary exercise testing as the primary outcome, the study aims to evaluate the efficacy of Qishen Granules on cardiac function, quality of life and biomarker level of patients with heart failure with preserved ejection fraction (HFpEF), which will provide evidence for the treatment of HFpEF with… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Qishen Granules
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
2 sitesChina
Study dates
1 May 2023to 30 Jun 2026
Phase
Interventional
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign the informed consent form
  • Age 18-85 years old
  • Heart failure was diagnosed ≥ 3 months before enrollment, The heart function classification II-IV of New York Heart Association (NYHA)
  • has ≥ 1 of the following: 1） Structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) recorded by echocardiography at the time of enrollment；2）Hospitalization due to heart failure within 12 months before enrollment
  • Retention of ejection fraction: left ventricular ejection fraction (LVEF)≥50% (Echocardiography)
  • Increase of NTpro-BNP (patients without atrial fibrillation>220pg/mL, patients with atrial fibrillation>660pg/mL
  • If diuretics are being administered orally, the dose must be stable for ≥ 2 weeks before inclusion in the study
  • At the time of randomization, it was clinically stable without signs of decompensation of cardiac failure (judged by the investigator)

Who cannot join

  • Patients with decompensated heart failure
  • Glomerular filtration rate (eGFR)<30mL/min/1.73m 2
  • Atrial fibrillation or atrial flutter with obvious liver disease or ALT, AST 3 times higher than the upper limit of normal
  • Symptomatic hypotension or systolic blood pressure (SBP)<100mmHg at the time of inclusion or baseline
  • Resting heart rate recorded by echocardiography at the time of screening>110bpm
  • Currently participating in another research equipment or drug test, or less than 30 days after the completion of another research equipment or drug test or receiving other research treatment. Patients participating in purely observational trials will not be excluded
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  • At present, people who are taking traditional Chinese medicine or Chinese patent medicine with similar effect to Qishen Granules
  • Be allergic to any component of Qishen granules (astragalus membranaceus, salvia miltiorrhiza, and black aconite)
  • Patients who refuse to sign the informed consent form or estimate poor compliance and women who are pregnant, nursing or planning to become pregnant during the trial

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lei Wang, doctorate contact

8620-81887233-3280

Dr.wanglei@139.com

China2 sites, 2 recruiting

  • Guangdong Provincial Hospital of Chinese Medicine

    Guangzhou, Guangdong, 510120

    Lei Wang, M.D, 8620-81887233-32801, Dr.wanglei@139.com

    Recruiting

  • WangLei

    Guangzhou, Guangdong, 510120

    Lei / Wang, doctorate, +8613724078381, Dr.wanglei@139.com

    Shuai / Mao, doctorate, 86-20-81887233-32801, maoshuaitcm@163.com

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study on the Treatment of Heart Failure with Preserved Ejection Fraction with Qishen Granules Based on Cardiopulmonary Exercise Test

With the cardiopulmonary exercise testing as the primary outcome, the study aims to evaluate the efficacy of Qishen Granules on cardiac function, quality of life and biomarker level of patients with heart failure with preserved ejection fraction (HFpEF), which will provide evidence for the treatment of HFpEF with traditional Chinese medicine.

Read the detailed description

Heart failure with preserved ejection fraction (HFpEF) is common and is associated with high morbidity and mor-tality in China. Studies have shown that traditional Chinese medicine (TCM) combined with conventional Western medicine has a good effect on improving exercise tolerance and quality of life in patients with HFpEF, but there are still some shortcomings that limit the reliability and extrapolation of results. Based on TCM theory and our decades of experience, we developed Qishen Granules for therapeutic use in the treatment of HFpEF. The good effect of Qishen Granules in patients with heart failure has been clinically verified before. In this study, cardiopulmonary exercise test (CPET) was used to evaluate the peak oxygen consumption (peak VO2), which is the gold standard assessment of aerobic capacity. Therefore, we selected VO2 peak as the primary outcome. At the same time, we conducted a preliminary assessment of the efficacy of Qishen Granules in improving the quality of life in patients with HFpEF, using Kansas City Cardiomyopathy Questionnaire (KCCQ) as the secondary outcome, and combined with other CPET indicators, echocardiographic measures, NT-pro BNP level, growth STimulation expressed gene 2 (ST2), biomarkers of liver and kidney function, and TCM Four-Dimensional Diagnostic Information Scale (TCMFDIS) to objectively, accurately, and comprehensively evaluate the efficacy and safety of Qishen Granules in improving quality of life and exercise capacity in patients with HFpEF.

Being tested
Qishen Granules, Placebo
Keywords
Heart Failure with Preserved Ejection Fraction, Qishen Granules, Cardiopulmonary Exercise Test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Qishen GranulesDrug

    One package per time, twice a day, 90 days of treatment

  • PlaceboDrug

    One package per time, twice a day, 90 days of treatment (the placebo was basically the same as Qishen granules in terms of appearance, shape, color, taste, etc.)

Study groups in NCT06377761
Study groupRoleWhat they receive
Qishen GranulesExperimentalOn the basis of standardized drug treatment for HFpEF, participants who met the inclusion criteria were randomly given Qishen Granule intervention on the day of inclusion, taking it twice a day for 90 days.
Receives: Drug: Qishen Granules
PlaceboPlacebo comparatorOn the basis of standardized drug treatment for HFpEF, participants who met the inclusion criteria were randomly given placebo granules on the day of inclusion, which were taken twice a day for 90 days (the placebo was basically the same as Qishen granules in terms of appearance, shape, color, taste, etc.)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in peak oxygen uptake within the average minute (PeakVO2) compared to baseline on day 90

    Measure the efficiency of peak oxygen intake by combining oxygen volume and time to report PeakVO2 in ml/min

    Measured: At enrollment versus at day 90

Secondary outcomes (9)

  1. Changes in Mitral valve diastolic blood flow velocity (E) and Mitral annulus lateral and septal motion velocity (e') compared to baseline on day 90

    Measure the blood flow velocity or motion velocity of specific areas in cm/s

    Measured: At enrollment versus at day 90

  2. Changes in E/e' ratio compared to baseline on day 90

    E/e' ratio

    Measured: At enrollment versus at day 90

  3. Changes in Left Atrial Volume index (LAVI) compared to baseline on day 90

    Left atrial volume (estimated from echocardiography measurement data) and body surface area (estimated based on height and weight) will be combined to report LAVI in ml/m^2

    Measured: At enrollment versus at day 90

  4. Changes in Left ventricular mass index (LVMI) compared to baseline on day 90

    Left ventricle mass (estimated from echocardiography measurement data) and body surface area (estimated based on height and weight) will be combined to report LVMI in g/m^2

    Measured: At enrollment versus at day 90

  5. Changes in Score of Kansas City Cardiomyopathy Questionnaire (KCCQ) compared to baseline on day 90

    Calculate the scores of the KCCQ questionnaire

    Measured: At enrollment versus at day 90

  6. Changes in blood N terminal pro B type natriuretic peptide(NT-proBNP) compared to baseline on day 90

    Level of blood NT-proBNP in mmol/L

    Measured: At enrollment versus at day 90

  7. Changes in blood Growth STimulation expressed gene 2(ST2) compared to baseline on day 90

    Level of blood ST2 in mmol/L

    Measured: At enrollment versus at day 90

  8. Changes in blood urea compared to baseline on day 90

    Level of blood urea in mmol/L

    Measured: At enrollment versus at day 90

  9. Changes in blood creatinine compared to baseline on day 90

    Level of blood creatinine in mmol/L

    Measured: At enrollment versus at day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2024
  2. Study start1 May 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Random parallel grouping
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06377761
Sponsor's protocol ID
BF-2022-121
Status last verified
Dec 2024
First submitted
2 Jun 2022
Last updated
18 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen H, Li Z, Su M, Song G, Guo S, Feng W, Chen W, Li C, Wang L, Wang W. Efficacy and safety of Qishen granule for treating heart failure with preserved ejection fraction: a study protocol for a multicenter, randomized, double-blind, placebo-controlled trial. BMC Complement Med Ther. 2025 Aug 6;25(1):298. doi: 10.1186/s12906-025-05029-z.

    PubMed 40770799

Questions about this trial

What is this clinical trial studying?

A study testing Qishen Granules in people with Heart Failure with Preserved Ejection Fraction, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 2 sites 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 9 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 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

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 Lei Wang, doctorate (8620-81887233-3280, Dr.wanglei@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in peak oxygen uptake within the average minute (PeakVO2) compared to baseline on day 90 (time frame: At enrollment versus at day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06377761, which also lists 1 linked publication.

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 18 Dec 2024.

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