Heart Failure Complicated with Constipation
Conditions
Interventions
Experimental group:Shouhui Tongbian capsule
Control group:Shouhui Tongbian capsule placebo
Sponsors
Dongzhimen Hospital Affiliated to Beijing University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 80 years old (inclusive), with no restriction on gender; 2. NYHA functional class ?–?; 3. Meet the Western medicine diagnostic criteria for heart failure, with LVEF < 50%; patients with HFrEF, HFimpEF and HFmrEF subtypes of heart failure are all included; 4. Meet the Western medicine diagnostic criteria for functional constipation; 5. Conform to the TCM syndrome differentiation diagnostic criteria of both heart failure and functional constipation; 6. Received guideline-directed medical therapy (GDMT) for heart failure for at least 4 weeks, with no acute decompensation events occurred within the recent 4 weeks; 7. The subjects voluntarily participate in the study with full informed consent and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Complicated with other severe or active cardiac diseases: such as acute coronary syndrome, untreated valvular heart disease with hemodynamic disorders, congenital heart disease, hypertrophic/restrictive/infiltrative cardiomyopathy, active myocarditis, acute pericarditis or cardiac tamponade, severe arrhythmia (high-grade atrioventricular block, malignant ventricular arrhythmia occurring within the recent 6 months); 2. Constipation caused by organic intestinal diseases, irritable bowel syndrome, drugs, etc., or complicated with severe or active gastrointestinal diseases: such as intestinal obstruction requiring emergency treatment, gastrointestinal bleeding, perforation, and other active inflammatory bowel diseases (Crohn's disease, ulcerative colitis); 3. Complicated with liver insufficiency (liver function indicators exceeding the normal range), renal insufficiency (glomerular filtration rate 5.5mmol/L); 4. Complicated with other uncontrolled severe systemic diseases: such as endocrine and metabolic diseases including poorly controlled hyperthyroidism or hypothyroidism, diabetes mellitus with severe acute complications (ketoacidosis, hyperosmolar state) or advanced chronic complications; active malignant tumors; severe hematological diseases; active autoimmune diseases, etc.; 5. Allergic to the study drug (Shouhui Tongbian Capsules or any of its components) or placebo components; 6. Pregnant women, women planning to become pregnant, and lactating women; patients with mental illness, cognitive impairment, or infectious diseases; 7. Participants who have participated in other studies within the recent 1 month; 8. According to the investigator's judgment, the patient cannot complete the study or cannot comply with the requirements of the study (due to administrative or other reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of complete spontaneous defecation >= 3 times per week (Rome IV core indicator); | — |
Secondary
| Measure | Time frame |
|---|---|
| patient assessment of constipation symptom, PAC SYM;patient assessment of constipation quality of life questionnaire, PAC-QOL;NT-proBNP;Minnesota Living with Heart Failure Questionnaire Score;Heart Failure Composite Endpoint (cardiovascular death or hospitalization for worsening heart failure);Traditional Chinese Medicine Syndrome Score Scale;hs-CRP;IL-6;TNF a;MDA;SOD;Zonulin;Lipopolysaccharide;Fecal Calprotectin; | — |
Countries
China
Contacts
Public ContactZhang Lijing
Dongzhimen Hospital Affiliated to Beijing University of Traditional Chinese Medicine
Outcome results
None listed