Heart failure with preserved left ventricular ejection fraction
Conditions
Interventions
Probiotics Group:Primary anti-HF therapy + clostridial enterococcus triple live tablet 400mg (2 tablet) orally, 3 times/day, for 12 weeks.
placebo group:Primary anti-HF therapy + placebo 2 tablets, orally, 3 times/day for 12 weeks.
Sponsors
The First Affiliated Hospital of Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
60 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1) age 60-90 years; 2) meet diagnostic criteria for HFpEF: 1 has the epidemiological and demographic characteristics of a patient with HFpEF; 2 presents with heart failure symptoms and/or signs; 3 cardiac imaging reveals LVEF =50%; 4 objective evidence of cardiac structural and/or functional abnormalities consistent with left ventricular dystonias and/or elevated left ventricular filling pressure, including elevation of either natriuretic peptide: BNP =35 pg/ml, NT-proBNP =125 pg/ml; 3) cardiac function NYHA class II~III; 4) current anti-HF regimen to be stably administered for at least 1 month; 5) stable current HF condition with no acute exacerbation; 6) cognitive function is essentially normal and daily activities are possible; 7) Understand the purpose of clinical trials, volunteer to participate and sign informed consent forms.
Exclusion criteria
Exclusion criteria: 1) hypersensitivity to Clostridium tuberosum enterococcus triple live bacterial tablets; 2) consecutive probiotic preparations taken within the first 3 months of enrollment and antibiotics taken within the first 3 months of enrollment; 3) had had a myocardial infarction in the 6 months prior to enrollment, had undergone coronary bypass surgery, or had any event that might have reduced LVEF (unless LVEF =50% has been confirmed); 4) perform valve replacement surgery within 6 months before enrollment; 5) poor blood pressure control (SBP=180mmHg or DBP=100mmHg); 6) current acute decompensated heart failure requiring treatment; 7) resting heart rate more than 120 beats/min, or complicated by malignant arrhythmias; 8) significant coronary artery lesions requiring PCI with revascularization; 9) severe renal impairment (blood creatinine >442µmol/L) or receiving dialysis; 10) current concurrent acute illnesses or acute exacerbations of chronic disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| KCCQ score; | — |
Secondary
| Measure | Time frame |
|---|---|
| NYHA class of cardiac function;6 minute walk distance;Minnesota Heart Failure Quality of Life Questionnaire Score;echocardiogram;Serum NT-proBNP Levels; | — |
Countries
China
Contacts
Public ContactSu Hui
The First Affiliated Hospital of Air Force Military Medical University
Outcome results
None listed