Heart failure
Conditions
Interventions
Control group:0.9% NaClinjection added to conventional therapies.
Treatment group:Yiqi Fumai for injection (0.65g/ bottle) 8 bottles added to conventional therapies.
Sponsors
Dongzhimen Hospital Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1: Age range: 18-80 years old gender not limited; 2: Meets the diagnostic criteria for HFpEF and has NYHA classification of heart function II-IV; 3: LVEF=50%; 4: NT-proBNP = 300pg/ml or BNP = 100pg/ml in patients with sinus rhythm and NT-proBNP = 900pg/ml or BNP = 300pg/ml in patients with atrial fibrillation; 5: Diagnosed as HFpEF within 3 months before screening; 6. Traditional Chinese Medicine diagnosis as Qi Yin deficiency and blood stasis type; 7: Voluntarily participate understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1: With non-surgical valvular heart disease or congenital heart disease; Combined hypertrophic obstructive cardiomyopathy restrictive cardiomyopathy and other secondary or invasive cardiomyopathy; Merge active myocarditis; Combined with constrictive pericarditis or other pericardial diseases; Symptomatic bradycardia or grade II or III heart block without pacemaker installed; 2: Complicated with severe liver dysfunction (liver function index value>3 times the normal value) renal dysfunction (glomerular filtration rate5.5 mmol/L) primary diseases such as blood system malignant tumors pulmonary embolism severe complications of diabetes severe endocrine diseases such as hyperthyroidism hypothyroidism or other uncontrollable systemic diseases; 3: Coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or cardiac synchronization therapy planned to undergo after randomization or had received cardiac resynchronization therapy prior to enrolment; 4: uncontrolled hypertension systolic blood pressure (SBP) = 180mmHg and/or diastolic blood pressure (DBP) = 110mmHg; or SBP < 90mmHg and/or DBP <60mmHg; 5: Women of child-bearing potential (i.e. those who are not chemically or surgically sterilized or who are not post-menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator from the time of signing the informed consent throughout the study and 4 weeks thereafter OR women who have a positive pregnancy test at enrolment or randomisation OR women who are breast-feeding; 6: Participation in another clinical study with an IP during the last month prior to enrolment; 7: Allergic constitution; known to be allergic to research drug; 8: Inability of the patient in the opinion of the investigator to understand and/or comply with study medications procedures or any conditions may render the patient unable to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change rate of NT-proBNP; | — |
Secondary
| Measure | Time frame |
|---|---|
| Echocardiographic indicators;Cardiovascular death and readmission events due to heart failure;NYHA heart function level;Six minutes walking test;KCCQ-TSS;Traditional Chinese Medicine symptom score; | — |
Countries
China
Contacts
Public ContactLijing Zhang
Dongzhimen Hospital Beijing University of Chinese Medicine
Outcome results
None listed