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NOT YET RECRUITING
NCT07628777
PHASE1/PHASE2

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

Sponsor: The First Affiliated Hospital of Air Force Medicial University

View on ClinicalTrials.gov

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.

Official title: Fecal Microbiota Transplantation for Elderly Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-06

Completion Date

2028-12-31

Last Updated

2026-06-05

Healthy Volunteers

No

Interventions

BIOLOGICAL

Fecal Microbiota Transplantation (FMT) Capsules

Bowel 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.

BIOLOGICAL

Placebo capsules

Bowel 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.

Locations (1)

The First Affiliated Hospital of Air Force Medical University

Xi’an, Shanxi, China