chronic heart failure
Conditions
Interventions
Experimental group:Standardized treatment of chronic heart failure + Qiliqiangxin Capsules, 4 capsules/time, 3 times/day, take orally
Control group:Standardized treatment of chronic heart failure + Placebo Capsules, 4 capsules/time, 3 times/day, take orally
Sponsors
The First Hospital Affiliated with Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Provision of signed informed consent prior to any study specific procedures; 2. Male or female, aged =18 years at the time of consent; 3. Established documented diagnosis of heart failure for at least three months ago according to Chinese Heart Failure Diagnosis and Treatment Guideline issued by the Chinese Medical Association Cardiovascular Branch; 4. Left ventricular ejection fraction (LVEF) =40% (echocardiogram, radionuclide, ventriculogram, contrast angiography or cardiac MRI); 5. NYHA cardiac functional grading II to III, with stable clinical symptoms; including those diagnosed as grade IV within 2 weeks before enrollment; 6. Serum NT-proBNP = 450pg/ml; 7. Those who have received standardized baseline treatment regimens without doses adjusted and given intravenously for at least two weeks prior to enrollment; standardized drug treatment includes: angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) or angiotensin receptor neprilysin inhibitor (ARNI), beta blocker, and aldosterone receptor antagonist (the optimal therapeutic dose should be achieved, except for contraindications or intolerance).
Exclusion criteria
Exclusion criteria: 1. Heart failure caused by valvular disease, congenital heart disease, pericardial disease, arrhythmia or non-cardiaogenic disease, or caused by vital organ failure (such as renal, hepatic failure, etc.); and right heart failure caused by pulmonary or other definite causes; and acute heart failure; 2. 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; 3. Any condition outside the CV diseases such as but not limited to malignant tumor, severe mental illness, hematopoietic diseases, neuroendocrine system disease, liver transaminase and alkaline phosphatase = 3 x upper limit of normal (ULN), abnormal renal function serum creatinine > 2 mg/dl (176.82 umol/L), potassium >5.5mmol/L; 4. Patient with left ventricular outflow tract obstruction, myocarditis, aortic aneurysm, aortic dissection, or obvious hemodynamic changes caused by unrepaired valve; 5. Cardiogenic shock, uncontrollable malignant arrhythmia, sinus or atrioventricular block at second degree type II or above without pacemaker treatment, progressive unstable angina pectoris or acute myocardial infarction; 6. uncontrolled hypertension systolic blood pressure (SBP) = 180mmHg and/or diastolic blood pressure (DBP) = 110mmHg; or SBP < 90mmHg and/or DBP <60mmHg; 7. Participation in another clinical study with an IP during the last month prior to enrolment; 8. 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; 10. Allergic constitution; known to be allergic to research drug; 11. 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 |
|---|---|
| The composite endpoint events consisting of cardiovascular death and re-hospitalization due to the worsening of heart failure; | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality;Secondary endpoint events (abandon treatment due to worsening heart failure, successful resuscitation after cardiac arrest, malignant arrhythmia, non-fatal stroke);The incidence of cardiovascular death and re-hospitalization due to worsening heart failure in patients with ischemic heart disease;Serum NT-proBNP decrease rate; | — |
Countries
China
Contacts
Public ContactXinli Li
The First Hospital Affiliated with Nanjing Medical University
Outcome results
None listed