Fecal Microbiota Transplantation for Elderly Patients With HFpEF: A Randomized Controlled Trial (NCT07628777) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Fecal Microbiota Transplantation for Elderly Patients With HFpEF: A Randomized Controlled Trial
China50 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Consistent with the epidemiological and demographic characteristics of HFpEF patients;
. Presence of clinical symptoms and/or signs of heart failure;
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score from Baseline to Week 20
Timeframe: Baseline, Week 4, Week 20
Trial details
NCT IDNCT07628777
SponsorThe First Affiliated Hospital of Air Force Medicial University
. Relative wall thickness \> 0.42, or left ventricular free wall thickness \> 12 mm;
Exclusion criteria
. 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;