Heart failure (HF)
Conditions
Interventions
Control group:Placebo
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary participation with understanding and signing of the informed consent form; 2.Age >=18 years and = 50% as determined by cardiac imaging (primarily echocardiography) during the screening period or within 6 months prior to the screening visit. Epidemiological and population characteristics consistent with HFpEF patients (according to the 2023 Chinese Expert Consensus on the Diagnosis and Treatment of HFpEF, an H2FPEF score >= 6 is considered diagnostic for HFpEF; a score between 2 and 5 requires further assessment as follows). Evidence of structural heart disease from echocardiography during the screening period or within 6 months prior, including at least one of the following: a. Left atrial (LA) enlargement, defined by any of the following: LA width (diameter) >= 3.8 cm, LA length >= 5.0 cm, LA area >= 20 cm², LA volume >= 55 ml, or LA volume index >=29 ml/m². b. Left ventricular hypertrophy (LVH), defined as interventricular septal or posterior wall thickness >= 1.1 cm. Sinus rhythm patients: BNP >= 35 pg/ml or NT-proBNP>= 125 pg/ml. Atrial fibrillation patients: BNP >= 105 pg/ml or NT-proBNP >= 365 pg/ml (adjusted for renal function as follows: BNP >= 200 pg/ml if eGFR = 1200 pg/ml if eGFR = 450 ng/L; for those 50–75 years: NT-proBNP >= 900 ng/L; for those over 75 years: NT-proBNP >= 1800 ng/L); 4.A history of hospitalization for heart failure or emergency visits due to heart failure within the past 2 years, with a confirmed diagnosis of heart failure at least 1 month prior; 5.Previously received guideline-directed medical therapy (GDMT) for at least 4 weeks in accordance with the 2024 Chinese Guidelines for the Diagnosis and Treatment of Heart Failure (meeting the following criteria): If no contraindications or intolerances exist, the patient should be on sodium-glucose co-transporter-2 inhibitors (SGLT2i) therapy. During the study, optimal treatment should be achieved based on guideline recommendations. For patients not treated with these medications according to the guidelines, the reasons should be documented.
Exclusion criteria
Exclusion criteria: 1.Hemodynamically unstable acute decompensated heart failure, as well as mechanical hemodynamic support or invasive mechanical ventilation within 14 days prior to randomization; intravenous inotropic agents, vasoactive medications, or intravenous diuretics administered within 7 days prior to randomization; 2.Poorly controlled hypertension, defined as resting systolic blood pressure >=180 mmHg and/or diastolic blood pressure >=110 mmHg on two independent measurements prior to randomization; 3.Liver transaminases (ALT or AST) and bilirubin exceeding three times the upper limit of normal, and glomerular filtration rate less than 20 ml/min/1.73m² due to non-heart failure causes; 4.Hemoglobin concentration <=9 g/dL and/or presence of hematologic diseases; 5.Unoperated valvular heart disease or congenital heart disease; 6.NYHA class IV or cardiogenic shock; 7.Hypertrophic cardiomyopathy, restrictive cardiomyopathy, other secondary and infiltrative cardiomyopathies; 8.Active myocarditis; 9.Constrictive pericarditis and other pericardial diseases; 10.Syncope history within the past 3 months; 11.Symptomatic bradycardia or second- or third-degree heart block without a pacemaker; 12.Malignant ventricular arrhythmias affecting hemodynamics; 13.Implantation of a cardiac resynchronization therapy pacemaker (CRT-P) or cardiac resynchronization therapy defibrillator (CRT-D) within the past 6 months, or upgrading an existing pacemaker or implantable cardioverter-defibrillator (ICD) to a CRT device, or intent to implant such a device within the past 6 months; 14.Acute coronary syndrome, stroke, transient ischemic attack, coronary artery bypass surgery, or other major vascular surgeries, percutaneous coronary intervention (PCI), carotid artery angioplasty, or coronary artery bypass grafting (CABG) within the past 3 months; 15.Major surgery within 6 months prior to randomization; 16.History of heart transplantation, awaiting transplantation, or intent to use a left ventricular assist device (LVAD); 17.Severe chronic obstructive pulmonary disease (COPD), cor pulmonale, severe pulmonary vascular disease, autoimmune disease-induced pulmonary arterial hypertension, or any type of severe pulmonary arterial hypertension; 18.History of major organ transplantation (e.g., lung, liver, heart, bone marrow, kidney); 19.Severe primary diseases of the liver, kidneys, hematologic system, nervous system, endocrine system, malignancies, or psychiatric disorders; 20.Life expectancy less than 1 year; 21.Known allergy to any study drug; 22.Participation in other drug clinical trials within the last month; 23.Use of Chinese herbal medicine or proprietary Chinese medicine with similar components to QiShenYiQi Droplets within the past month; 24.Pregnancy (positive pregnancy test) or breastfeeding; women of childbearing age who do not use adequate contraception; 25.Judgment by the investigator that the patient cannot complete the study or comply with the study requirements (due to management reasons or other reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| myocardial flow reserve, MFR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Myocardial Blood Flow;High-frequency QRS Electrocardiographic Monitoring for Myocardial Ischemia;Symptoms and their quality of life;NYHA functional classification.;6-minute walk test.;Outcome events and composite endpoint events.; | — |
Countries
China
Contacts
Public ContactLi Dianfu
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed