Study on Heart Failure with Preserved Ejection Fraction with Qishen Granules
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorGuangdong Provincial Hospital of Traditional Chinese Medicine
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Qishen Granules
DrugOne package per time, twice a day, 90 days of treatment
Placebo
DrugOne 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.)
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Qishen GranulesExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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
Time frame
At enrollment versus at day 90Secondary outcomes
1
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
Time frame
At enrollment versus at day 902
Changes in E/e' ratio compared to baseline on day 90
E/e' ratio
Time frame
At enrollment versus at day 903
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
Time frame
At enrollment versus at day 904
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
Time frame
At enrollment versus at day 90Other outcomes
1
Changes in Aspartate aminotransferase(AST) compared to baseline on day 90
Level of blood AST in mmol/L
Time frame
At enrollment versus at day 902
Changes in Alanine aminotransferase(ALT) compared to baseline on day 90
Level of blood ALT in mmol/L
Time frame
At enrollment versus at day 903
Number of participants with treatment-related adverse events
Assess the incidence of treatment-related adverse events
Time frame
At enrollment versus at day 90Sponsors and contacts
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Source ClinicalTrials.gov