Chronic heart failure
Conditions
Interventions
Experimental group:The standard treatment of Western medicine combined with shenfu Jiangtang decoction (1 bag at 9g each taken orally twice daily with warm water) for 8 weeks
Control group:The standard treatment of Western medicine combined with placebo (1 bag at 9g each, taken orally twice daily with warm water) for 8 weeks
Sponsors
Putuo Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Aged between 18 and 80 years regardless of gender. (2) Meeting the diagnostic criteria for chronic heart failure. (3) Meeting the diagnostic criteria for type 2 diabetes mellitus. (4) New York Heart Association (NYHA) classification stages II-IV. (5) Serum NT-proBNP level =125 pg/mL. (6) Diagnosed with Qi deficiency and blood stasis syndrome according to traditional Chinese medicine syndrome differentiation. (7) Those who volunteered to participate in this study and signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with left ventricular outflow tract obstruction myocarditis large or dissecting aneurysms or significant hemodynamic changes and those experiencing cardiogenic shock uncontrollable malignant arrhythmias progressively worsening unstable angina or acute myocardial infarction. (2) Heart failure due to organic diseases such as valvular heart disease congenital heart disease or patients existing acute myocardial infarction within the one month. (3) Patients scheduled for coronary revascularization or cardiac resynchronization therapy in the near future or having received coronary revascularization or cardiac resynchronization therapy within the one month. (4) Uncontrolled hypertension with systolic blood pressure =180 mmHg and/or diastolic blood pressure =110 mmHg. (5) Acute diabetic complications such as diabetic ketoacidosis or hyperosmolar coma occurred within the one month. (6) Patients with psychiatric disorders or those with malignant progressive diseases and an expected survival of less than one year as assessed by clinicians. (7) Patients with a history of drug allergies or known hypersensitivity to treatment components. (8) Patients who had participated in other clinical drug trials within one month. (9) Pregnant or lactating women. (10) Patients not meeting the inclusion criteria unwilling to sign the informed consent or considered by the investigators to be unable to complete the study or comply with study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak oxygen consumption during cardiopulmonary exercise testing; | — |
Secondary
| Measure | Time frame |
|---|---|
| Thyroid function;Echocardiography;Minnesota Living with Heart Failure questionnaire;Glycosylated hemoglobin;6-min walking test;Homeostatic model assessment of insulin resistance;Traditional Chinese Medicine syndrome score;New York Heart Association (NYHA) classification;Body mass index;N-terminal B-type natriuretic peptide precursor (NT-proBNP);Fasting insulin;Glycated albumin;Insulin sensitivity index;Soluble growth stimulation expressed gene 2 protein (ST2);Cardiopulmonary exercise testing;Fasting plasma glucose;Homocysteine; | — |
Countries
China
Contacts
Public ContactZongjun Liu
Putuo Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed