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Recruiting Not applicable

Study on Heart Failure with Preserved Ejection Fraction with Qishen Granules

NCT06377761 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2023-05-01
Last updated
2024-12-18

Condition(s) studied

Heart Failure with Preserved Ejection Fraction

Investigational drug(s) / intervention(s)

Qishen GranulesPlacebo

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

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.)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Changes in peak oxygen uptake within the average minute (PeakVO2) compared to baseline on day 90 — At enrollment versus at day 90
    Measure the efficiency of peak oxygen intake by combining oxygen volume and time to report PeakVO2 in ml/min

Trial sites (2)

FacilityCityRegionStatus
Guangdong Provincial Hospital of Chinese Medicine Guangzhou Guangdong Recruiting
WangLei Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06377761 on ClinicalTrials.gov ↗ ← All trials in China