This is a single-center, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) in elderly patients with heart failure with preserved ejection fraction (HFpEF).
HFpEF is a common type of heart failure in older adults, often associated with poor quality of life and frequent hospitalizations. Recent research suggests that changes in gut bacteria may contribute to the progression of HFpEF. FMT aims to restore a healthy gut microbiome, which may improve heart function and reduce symptoms.
Participants will be randomly assigned to receive either FMT or a placebo treatment. The primary goal is to compare changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score between the two groups at 20 weeks. Secondary goals include assessing improvements in exercise capacity (6-minute walk test), NYHA functional class, and safety outcomes.
The study will enroll 50 elderly patients (aged ≥60 years) with confirmed HFpEF. All participants will receive standard medical care for HFpEF throughout the study. This trial is sponsored by The First Affiliated Hospital of Air Force Medical University and conducted in accordance with ethical standards.
1.Aged ≥ 60 years old;
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%;
1.Symptoms caused by non-cardiac diseases;
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;
Parallel
Fecal Microbiota Transplantation (FMT) Capsules
Biological/VaccineBowel preparation with polyethylene glycol (PEG) before treatment, followed by oral administration of fecal microbiota transplantation (FMT) capsules. Patients will receive standard HFpEF medical care throughout the study.
Placebo capsules
Biological/VaccineBowel preparation with polyethylene glycol (PEG) before treatment, followed by oral administration of identical-appearing placebo capsules. Patients will receive standard HFpEF medical care throughout the study.
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score from Baseline to Week 20
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a validated patient-reported outcome measure assessing heart failure-specific quality of life. The change in the overall summary score from baseline to week 20 will be compared between the FMT group and the placebo group. Higher scores indicate better health status.
Change in NYHA Functional Class from Baseline to Week 20
New York Heart Association (NYHA) functional classification is used to assess the severity of heart failure symptoms. Changes in NYHA class from baseline to week 20 will be compared between groups.
Change in 6-Minute Walk Test (6MWT) Distance from Baseline to Week 20
The 6-minute walk test is a measure of functional capacity in patients with heart failure. The distance walked in 6 minutes will be assessed at baseline, week 4, and week 20 to evaluate changes in exercise tolerance.
Change in Serum N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) Level from Baseline to Week 20
Serum NT-proBNP is a key biomarker for heart failure severity. Levels will be measured at baseline, week 4, and week 20 to assess changes in cardiac strain.
Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total Score from Baseline to Week 20
The MLHFQ is a patient-reported questionnaire evaluating the impact of heart failure on quality of life. Higher scores indicate greater impairment. Changes from baseline to week 20 will be compared.
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