Chronic heart failure
Conditions
Interventions
Control Group:On the basis of conventional western medicine treatment, combined with the Heart Failure Patch placebo (which contains 5% of the active ingredient of the original drug)
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) aged between 18 and 80 years old;(2) meet the diagnostic criteria for stable chronic heart failure;(3) New York Heart Association (NYHA) functional class II-III;(4) patients with reduced ejection fraction (LVEF < 40%);(5) The syndrome of Yang qi deficiency and blood stasis combined with phlegm and drink;(6) Lee's heart failure score =6;(7) The subjects had fully informed consent to participate in this study voluntarily, and signed the informed consent form by themselves.
Exclusion criteria
Exclusion criteria: (1) Heart failure due to kidney, liver and other important organ failure;(2) Patients with severe heart failure or grade IV heart function were not included in the study.(3) presence of various malignant tumors or suspicious malignant tumors;(4) history of thrombotic disease within 6 months;(5) patients with obvious liver and kidney diseases or ALT and AST higher than ULN 1.5 times, creatinine and urea nitrogen higher than ULN 1.5 times;(6) patients with severe mental disorders, hematopoietic system diseases and other major diseases;(7) women who are pregnant, lactating or have a positive pregnancy test, or have plans to give birth within a certain period of time;(8) patients with redness, swelling, ulceration or skin diseases;(9) have participated or are participating in other clinical investigators within the past three months;(10) Patients with suspected or confirmed allergy to the study drug or topical patch;(11) Factors that increase mortality: Patients with cardiogenic shock, severe ventricular arrhythmia, complete atrioventricular block, obstructive cardiomyopathy, unpatched valvular disease, constrictive pericarditis, pericardial tamponade, pulmonary embolism, obvious infection, uncontrolled hypertension, acute myocarditis, acute coronary syndrome, and chronic heart failure requiring device therapy were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minnesota Quality of Life in Heart Failure Questionnaire; | — |
Secondary
| Measure | Time frame |
|---|---|
| 24-hour urine output;Efficacy evaluation of TCM syndromes;N-Terminal Pro-Brain Natriuretic Peptide;Lee's score for heart failure;Left Ventricular Ejection Fraction;NYHA cardiac function classification; | — |
Countries
China
Contacts
Public ContactXin Wang
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed