Heart Failure With Preserved Ejection Fraction Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Guangdong Provincial Hospital of Chinese Medicine | Guangzhou | Guangdong |
China | WangLei | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangdong Provincial Hospital of Traditional Chinese Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes in Aspartate aminotransferase(AST) compared to baseline on day 90 | Level of blood AST in mmol/L | At enrollment versus at day 90 | |
Other | Changes in Alanine aminotransferase(ALT) compared to baseline on day 90 | Level of blood ALT in mmol/L | At enrollment versus at day 90 | |
Other | Number of participants with treatment-related adverse events | Assess the incidence of treatment-related adverse events | At enrollment versus at day 90 | |
Primary | 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 | Changes in Mitral valve diastolic blood flow velocity (E) and Mitral annulus lateral and septal motion velocity (e') compared to baseline on day 90 | Measure the blood flow velocity or motion velocity of specific areas in cm/s | At enrollment versus at day 90 | |
Secondary | Changes in E/e' ratio compared to baseline on day 90 | E/e' ratio | At enrollment versus at day 90 | |
Secondary | Changes in Left Atrial Volume index (LAVI) compared to baseline on day 90 | Left atrial volume (estimated from echocardiography measurement data) and body surface area (estimated based on height and weight) will be combined to report LAVI in ml/m^2 | At enrollment versus at day 90 | |
Secondary | Changes in Left ventricular mass index (LVMI) compared to baseline on day 90 | Left ventricle mass (estimated from echocardiography measurement data) and body surface area (estimated based on height and weight) will be combined to report LVMI in g/m^2 | At enrollment versus at day 90 | |
Secondary | Changes in Score of Kansas City Cardiomyopathy Questionnaire (KCCQ) compared to baseline on day 90 | Calculate the scores of the KCCQ questionnaire | At enrollment versus at day 90 | |
Secondary | Changes in blood N terminal pro B type natriuretic peptide(NT-proBNP) compared to baseline on day 90 | Level of blood NT-proBNP in mmol/L | At enrollment versus at day 90 | |
Secondary | Changes in blood Growth STimulation expressed gene 2(ST2) compared to baseline on day 90 | Level of blood ST2 in mmol/L | At enrollment versus at day 90 | |
Secondary | Changes in blood urea compared to baseline on day 90 | Level of blood urea in mmol/L | At enrollment versus at day 90 | |
Secondary | Changes in blood creatinine compared to baseline on day 90 | Level of blood creatinine in mmol/L | At enrollment versus at day 90 |
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