Fecal Microbiota Transplantation for Elderly Patients With HFpEF: A Randomized Controlled Trial

Prior treatment

• 4.Received valve replacement surgery within 6 months before enrollment;

Other illness

• 1.Symptoms caused by non-cardiac diseases;
• 6.Current acute decompensated heart failure requiring intervention;
• 7.Resting heart rate \> 120 beats per minute, or complicated with malignant arrhythmia;
• 8.Significant coronary artery disease requiring PCI revascularization;
• 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;

Lab values

• 2.Patients with any contraindication to Fecal Microbiota Transplantation (FMT):
  • Patients with severe intestinal barrier damage induced by various causes, such as sepsis, active massive gastrointestinal bleeding, intestinal perforation;
  • Patients diagnosed with fulminant colitis or toxic megacolon;
  • 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;
  • Patients with congenital or acquired immunodeficiency diseases;
  • 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;
  • Severely immunosuppressed patients with neutrophil count \< 1500/mm³;
• 3.History of myocardial infarction, coronary artery bypass grafting, or any event that may reduce LVEF within 6 months before enrollment (unless LVEF ≥ 50% was confirmed);
• 9.Severe renal insufficiency (serum creatinine \> 442 μmol/L) or patients on dialysis;

Other

• 5.Poorly controlled blood pressure (SBP ≥ 180 mmHg or DBP ≥ 100 mmHg);
• 13.Participation in other interventional clinical trials or oral intake of probiotic preparations within the past 3 months.

• 1.Aged ≥ 60 years old;
• 2.Meeting the diagnostic criteria for HFpEF:
  • Consistent with the epidemiological and demographic characteristics of HFpEF patients;
  • Presence of clinical symptoms and/or signs of heart failure;
  • Cardiac imaging examination indicating LVEF ≥ 50%;
  • 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;
  • Meet at least one of the following conditions:
  • LVMI ≥ 115 g/m² (male) or ≥ 95 g/m² (female);
  • LAVI \> 34 ml/m²;
  • Relative wall thickness \> 0.42, or left ventricular free wall thickness \> 12 mm;
  • Septal e' \< 7 cm/s, or lateral e' \< 10 cm/s, or average E/e' ≥ 14;
  • Tricuspid regurgitation velocity \> 2.8 m/s, or pulmonary artery systolic pressure \> 35 mmHg;
• 3.NYHA functional class Ⅱ-Ⅲ;
• 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.