Heart failure
Conditions
Interventions
Experimental group:GDMT combined with Shexiang Tongxin dropping pills
Control group:GDMT combined with Shexiang Tongxin dropping pills
Sponsors
The Second Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. One Age ranged from 18 to 80 years old, both sexes. 2. Having symptoms and/or signs of heart failure and a history of decompensated HF (defined as hospitalization for HF or diuretic therapy without hospitalization for HF) within 6 months before randomization; 3. Echocardiography during the screening period showed LVEF > = 50% and NYHA heart function class ?-?. 4. Elevated level of natriuretic peptide: NT-proBNP > 125pg/ml in patients with sinus rhythm; NT-proBNP > 365pg/ml in patients with AF; 5. Presence of changes in at least one of the following structural and/or functional parameters: (1) presence of one of the following changes on echocardiography during screening: a. Left ventricular hypertrophy (any of the following: interventricular septum or left ventricular posterior wall thickness > = 1.1 cm, and/or left ventricular mass index > = 115 g/m2 in men and > = 95 g/m2 in women); b. E/e '= > = 14; c. LA enlargement (left atrial volume index > = 34 mL/m2, or left atrial volume: male >58 mL, female >52 mL, or LA area >20 cm2, or LA diameter >40 mm); (2) Pulmonary capillary wedge pressure > = 15mmHg or left ventricular end-diastolic pressure > = 16mmHg at rest; (3) Stress cardiac catheterization: pulmonary capillary wedge pressure during peak exercise > = 25mmHg; 6. Fully understand the purpose of the study, patients have good compliance with the trial, and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. One Patients with severe aortic and mitral valve insufficiency and/or stenosis; 2. Patients with hypertrophic obstructive cardiomyopathy (left ventricular outflow tract transient peak pressure gradient > = 30mmHg), infiltrative cardiomyopathy (such as myocardial amyloidosis or Fabry cardiomyopathy), acute myocarditis, constrictive pericarditis; 3. Patients with cardiac dysfunction caused by extracardiac diseases, such as severe anemia (hemoglobin = 5×ULN, AST > = 5×ULN), renal insufficiency (eGFR < 15 ml/min/1.73m2); 6. Women planning to become pregnant, pregnant or breastfeeding; 7. Patients who were unable to perform the 6MWT due to physical impairment or other non-cardiac reasons; 8. Have participated or are participating in other drug clinical trials within 3 months before screening; Other investigators considered it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 minutes walking test distance; | — |
Secondary
| Measure | Time frame |
|---|---|
| N-terminal fragment brain natriuretic peptides,NT-proBNP;Cardiac function classification;Changes of echocardiographic parameters;Compound end point event, MACE;Kansas City cardiomyopathy questionnaire, KCCQ;Laboratory examination; | — |
Countries
China
Contacts
Public ContactLiang Chun
The Second Affiliated Hospital of Naval Medical University
Outcome results
None listed