Study on Heart Failure with Preserved Ejection Fraction with Qishen Granules
Recruiting · NCT06377761 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboQishen Granules
What this trial is about
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.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
- 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
Where it is running
2 locations listed.
- Guangdong Provincial Hospital of Chinese Medicine - Guangzhou, Guangdong, China
- WangLei - Guangzhou, Guangdong, China