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Study on Heart Failure with Preserved Ejection Fraction with Qishen Granules

NCT ID: NCT06377761

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Failure with Preserved Ejection Fraction

Keywords

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Heart Failure with Preserved Ejection Fraction Qishen Granules Cardiopulmonary Exercise Test

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Random parallel grouping
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Qishen Granules

On 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.

Group Type EXPERIMENTAL

Qishen Granules

Intervention Type DRUG

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

Placebo

On 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.)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.)

Interventions

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Qishen Granules

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

Intervention Type DRUG

Placebo

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.)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Sign the informed consent form
2. Age 18-85 years old
3. Heart failure was diagnosed ≥ 3 months before enrollment, The heart function classification II-IV of New York Heart Association (NYHA)
4. 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
5. Retention of ejection fraction: left ventricular ejection fraction (LVEF)≥50% (Echocardiography)
6. Increase of NTpro-BNP (patients without atrial fibrillation\>220pg/mL, patients with atrial fibrillation\>660pg/mL
7. If diuretics are being administered orally, the dose must be stable for ≥ 2 weeks before inclusion in the study
8. At the time of randomization, it was clinically stable without signs of decompensation of cardiac failure (judged by the investigator)

Exclusion Criteria

1. Patients with decompensated heart failure
2. Glomerular filtration rate (eGFR)\<30mL/min/1.73m 2
3. Atrial fibrillation or atrial flutter with obvious liver disease or ALT, AST 3 times higher than the upper limit of normal
4. Symptomatic hypotension or systolic blood pressure (SBP)\<100mmHg at the time of inclusion or baseline
5. Resting heart rate recorded by echocardiography at the time of screening\>110bpm
6. 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
7. At present, people who are taking traditional Chinese medicine or Chinese patent medicine with similar effect to Qishen Granules
8. Be allergic to any component of Qishen granules (astragalus membranaceus, salvia miltiorrhiza, and black aconite)
9. 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Lei Wang,MD

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lei Wang, doctorate

Role: STUDY_DIRECTOR

Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China

Locations

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Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Site Status RECRUITING

WangLei

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Wang, doctorate

Role: CONTACT

Phone: 8620-81887233-3280

Email: [email protected]

Facility Contacts

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Lei Wang, M.D

Role: primary

Lei / Wang, doctorate

Role: primary

Shuai / Mao, doctorate

Role: backup

References

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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.

Reference Type DERIVED
PMID: 40770799 (View on PubMed)

Other Identifiers

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BF-2022-121

Identifier Type: -

Identifier Source: org_study_id