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

Prior treatment

• 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
• 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
• Participate in clinical trials of other drugs within 3 months before screening

Other illness

• 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
• Allergic constitution, or allergic to the test drug or its ingredients

Lab values

• People with any of the following cardiovascular diseases:
  • 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
  • Clinical evidence of acute coronary syndrome (including myocardial infarction, unstable angina pectoris) within 6 months before screening stage
  • Received prior revascularization (such as PCI, CABG), or implantable cardioverter defibrillator (ICD), or other cardiac/cardiovascular procedures within 3 months before screening stage
  • Received cardiac resynchronization therapy (CRT) within 6 months before screening stage
  • 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
  • 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
  • Patients with pulmonary artery embolism caused by pulmonary hypertension, chronic obstructive pulmonary disease and other serious pulmonary diseases
  • Hypertension that is difficult to control with medication (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg)
  • 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
• Hemoglobin \< 9.0 g/dL

Other

• Women who are pregnant or lactating
• The researchers did not consider it appropriate to participate in this study

• Male or female subjects aged ≥ 18 years
• Diagnosed as chronic heart failure with preserved ejection fraction according to the Guidelines for Diagnosis and Treatment of Heart Failure in China 2018
  • Have symptoms and/or signs of chronic heart failure at least 30 days before the trial
  • LVEF≥50% according to echocardiography during screening stage
  • BNP \> 35 ng/L and/or NT-proBNP \> 125 ng/L
  • Cardiac structural changes or diastolic dysfunction according to echocardiography during screening stage, in line with at least one of the following:
  • : LAVI\>34ml/m2
  • : E/e'≥13
  • : average e'(interventricular septum and free wall)\<9cm/s
• NYHAⅡ-Ⅲ
• Patients with hypertension received a stable dose of antihypertensive therapy for at least 4 weeks and kept their blood pressure at an ideal level for at least 4 weeks
• Ability to understand the requirements of the study and willingness to provide written informed consent
• Have no pregnancy program and take effective contraceptive measures voluntarily
• Abide by the experimental protocol and cooperate with the data collection according to the researcher's judgment