Efficacy and Safety of Qishenyiqi Dripping Pills for Treating Chronic Heart Failure With Preserved Ejection Fraction

Exclusion Criteria

• •People with any of the following cardiovascular diseases:
• •1. Patients with acute decompensated heart failure who need to use quick-acting diuretics, vasodilators, or positive inotropic drugs for treatment, or in the adjustment period of acute decompensated heart failure treatment, and the adjustment time is less than 1 month
• •2. Clinical evidence of acute coronary syndrome (including myocardial infarction, unstable angina pectoris) within 6 months before screening stage
• •3. Received prior revascularization (such as PCI, CABG), or implantable cardioverter defibrillator (ICD), or other cardiac/cardiovascular procedures within 3 months before screening stage
• •4. Received cardiac resynchronization therapy (CRT) within 6 months before screening stage
• •5. Implantable devices (e.g. ICD, CRT), revascularization (e.g. PCI, CABG), or other cardiac/cardiovascular procedures are expected to be performed during the trial period
• •6. Patients with acute myocarditis, invasive cardiomyopathy, constrictive pericarditis, cardiac tamponade, hypertrophic obstructive cardiomyopathy, cardiac shock, hemodynamic abnormalities of heart valve disease significantly narrow and/or regurgitation (moderate or above, etc.), Ⅱ degrees above Ⅱ type atrioventricular block placement pacemaker therapy, average QTc \> 450 ms or heart rate \< 50 times/min
• •7. Patients with pulmonary artery embolism caused by pulmonary hypertension, chronic obstructive pulmonary disease and other serious pulmonary diseases
• •8. Hypertension that is difficult to control with medication (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg)
• •9. Symptomatic hypotension and/or systolic blood pressure \<100 mmHg
• •Severe renal insufficiency: eGFR \< 30 ml/min/1.73m2
• •ALT and AST \> 3 times upper the limit of normal values in local laboratories, and/or total bilirubin \> 2 times upper the limit of normal values in local laboratories
• •Serum potassium ≥5.5 mmol/L
• •HbA1c≥9.0%, or fasting blood glucose \>13.9 mmol/L
• •Diabetic patients who are using sodium-glucose cotransporter 2 inhibitors and cannot stop using them during the trial, such as dagliredin, entagliredin, and cagliredin
• •The ECG examination indicated the onset of atrial fibrillation during the screening period or previous history of atrial fibrillation within 6 months before screening stage
• •Hemoglobin \< 9.0 g/dL
• •Patients have stroke 3 months before the screening period
• •Concomitant mental illness and poor condition control, which affects the signing of informed consent or presentation of adverse events
• •Patients with active malignancies (including those currently under oncology treatment)
• •Unable to conduct the 6-minute walking distance test due to physical impairment or other non-cardiac reasons
• •Women who are pregnant or lactating
• •Allergic constitution, or allergic to the test drug or its ingredients
• •Participate in clinical trials of other drugs within 3 months before screening
• •The researchers did not consider it appropriate to participate in this study