Tests Qishen Granules against placebo in heart failure with preserved ejection fraction
Tests Qishen Granules versus placebo in adults with heart failure with preserved ejection fraction.
Plain-language title generated from the registry record
Registry title: Study on Heart Failure with Preserved Ejection Fraction with Qishen Granules
Key facts
- Where
- Guangzhou, ChinaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT06377761, who can take part
Where in China
- Guangdong Provincial Hospital of Chinese MedicineGuangzhou, ChinaTaking people
- WangLeiGuangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Trial code
- NCT06377761
- Record updated
- 18 December 2024
- Original description
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 full original descriptionShow less
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.
Inclusion: 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).
Exclusion: 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; Patients with decompensated heart failure; Resting heart rate recorded by echocardiography at the time of screening>110bpm; Be allergic to any component of Qishen granules (astragalus membranaceus, salvia miltiorrhiza, and black aconite); 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; At present, people who are taking traditional Chinese medicine or Chinese patent medicine with similar effect to Qishen Granules; 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.