Heart Failure with Preserved Ejection Fraction
Conditions
Interventions
Treatment group:fecal microbiota transplantation capsules
Sponsors
The First Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged = 60 years old; 2.Meeting the diagnostic criteria for HFpEF: (1) Consistent with the epidemiological and demographic characteristics of HFpEF patients; (2)Presence of clinical symptoms and/or signs of heart failure; (3)Cardiac imaging examination indicating LVEF = 50%; (4) In sinus rhythm: BNP = 35 pg/ml and/or NT-proBNP = 125 pg/ml; In atrial fibrillation: BNP = 105 pg/ml and/or NT-proBNP = 365 pg/ml; (5) Meet at least one of the following conditions: 1) LVMI >= 115 g/m^2 (male) or >= 95 g/m^2 (female); 2) LAVI > 34 ml/m^2; 3) Relative wall thickness > 0.42, or left ventricular free wall thickness > 12 mm; 4) Septal e' = 14; 5) Tricuspid regurgitation velocity > 2.8 m/s, or pulmonary artery systolic pressure > 35 mmHg. 3.NYHA functional class ?–?; 4.Complicated with metabolic diseases such as hypertension, diabetes and obesity; 5.Accompanied by gastrointestinal symptoms; 6.Well-tolerated to current anti-heart failure regimens with stable medication for at least 1 month; 7.Stable heart failure condition without acute exacerbation; 8.Basically normal cognitive function, capable of understanding scale assessment contents; 9.Able to perform daily activities independently; 10.Fully understanding the purpose of this clinical trial, voluntary participation and signing of written informed consent.
Exclusion criteria
Exclusion criteria: 1.Symptoms caused by non-cardiac diseases; 2.Patients with any contraindication to Fecal Microbiota Transplantation (FMT): (1) Patients with severe intestinal barrier damage induced by various causes, such as sepsis, active massive gastrointestinal bleeding, intestinal perforation; (2) Patients diagnosed with fulminant colitis or toxic megacolon; (3) Patients unable to tolerate enteral nutrition meeting 50% of calorie requirements due to severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinal hemorrhage, high-output intestinal fistula and other conditions; (4) Patients with congenital or acquired immunodeficiency diseases; (5) Patients receiving high-risk immunosuppressive or cytotoxic drugs recently, such as rituximab, doxorubicin, or moderate-to-high dose steroids (prednisone = 20 mg/d) administered continuously for more than 4 weeks; (6) Severely immunosuppressed patients with neutrophil count 120 beats per minute, or complicated with malignant arrhythmia; 8.Significant coronary artery disease requiring PCI revascularization; 9.Severe renal insufficiency (serum creatinine > 442 µmol/L) or patients on dialysis; 10.Pre-existing gastrointestinal diseases, including ulcerative colitis, Crohn’s disease, irritable bowel syndrome, chronic diarrhea; 11.Current malignant tumors requiring anti-tumor treatment; 12.Complicated with acute diseases or acute exacerbation of chronic diseases at present; 13.Participation in other interventional clinical trials or oral intake of probiotic preparations within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kansas City Cardiomyopathy Questionnaire quality-of-life score; | — |
Secondary
| Measure | Time frame |
|---|---|
| New York Heart Association functional classification;6-minute walking distance;serum NT-proBNP level;Minnesota Living with Heart Failure Questionnaire score;echocardiographic indicators;inflammatory markers;Gut microbiome characteristics;gut microbiota metabolites;intestinal barrier function;nutrition; | — |
Countries
China
Contacts
Public ContactHui Su
The First Affiliated Hospital of Air Force Medical University
Outcome results
None listed