Study on Heart Failure with Preserved Ejection Fraction with Qishen Granules

NCT06377761 | Recruiting

• 1 other identifier: BF-2022-121
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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 traditional Chinese medicine.

Conditions

Heart Failure with Preserved Ejection Fraction

Keywords

Heart Failure with Preserved Ejection Fraction; Qishen Granules; Cardiopulmonary Exercise Test

Outcome Measures

Primary Outcomes (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

  At enrollment versus at day 90

Secondary Outcomes (9)

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

  At enrollment versus at day 90

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

  At enrollment versus at day 90

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

  At enrollment versus at day 90

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

  At enrollment versus at day 90

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

  At enrollment versus at day 90

Other Outcomes (3)

• Changes in Aspartate aminotransferase(AST) compared to baseline on day 90

  At enrollment versus at day 90

• Changes in Alanine aminotransferase(ALT) compared to baseline on day 90

  At enrollment versus at day 90

• Number of participants with treatment-related adverse events

  At enrollment versus at day 90

Study Arms (2)

Qishen Granules

EXPERIMENTAL

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.

Drug: Qishen Granules

Placebo

PLACEBO COMPARATOR

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.)

Drug: Placebo

Interventions

Qishen Granules DRUG

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

Qishen Granules

Placebo 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.)

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• At the time of randomization, it was clinically stable without signs of decompensation of cardiac failure (judged by the investigator)

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine: lead

Study Sites (2)

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

RECRUITING

WangLei

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40770799 DERIVED

Study Officials

• Lei Wang, doctorate

  Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China

  STUDY DIRECTOR

Central Study Contacts

Lei Wang, doctorate

CONTACT

8620-81887233-3280; Dr.wanglei@139.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: Random parallel grouping

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: April 22, 2024
• Study Start: May 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)