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

NCT07628777 | Not Yet Recruiting Phase 1

• 1 other identifier: KY20252186-F-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Heart Failure; Heart Failure With Preserved Ejection Fraction (HFPEF)

Keywords

Heart Failure with Preserved Ejection Fraction; HFpEF; Fecal Microbiota Transplantation; FMT

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 4, Week 20

Secondary Outcomes (33)

• Change in NYHA Functional Class from Baseline to Week 20

  Baseline, Week 4, Week 20

• Change in 6-Minute Walk Test (6MWT) Distance from Baseline to Week 20

  Baseline, Week 4, Week 20

• Change in Serum N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) Level from Baseline to Week 20

  Baseline, Week 4, Week 20

• Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total Score from Baseline to Week 20

  Baseline, Week 4, Week 20

• Change in Serum Inflammatory Biomarkers (NLRP3, IL-1β, TNF-α, IL-6, MCP-1, ICAM-1, VCAM-1) from Baseline to Week 20

  Baseline, Week 4, Week 20

Study Arms (2)

Fecal Microbiota Transplantation (FMT) Group

EXPERIMENTAL

Biological: Fecal Microbiota Transplantation (FMT) Capsules

Placebo Control Group

PLACEBO COMPARATOR

Biological: Placebo capsules

Interventions

Fecal Microbiota Transplantation (FMT) Capsules BIOLOGICAL

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.

Fecal Microbiota Transplantation (FMT) Group

Placebo capsules BIOLOGICAL

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.

Placebo Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 60 years old;
• 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;
• NYHA functional class Ⅱ-Ⅲ;
• Complicated with metabolic diseases such as hypertension, diabetes and obesity;
• Accompanied by gastrointestinal symptoms;

You may not qualify if:

• Symptoms caused by non-cardiac diseases;
• 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;
• 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);
• Received valve replacement surgery within 6 months before enrollment;
• Poorly controlled blood pressure (SBP ≥ 180 mmHg or DBP ≥ 100 mmHg);
• Current acute decompensated heart failure requiring intervention;
• Resting heart rate \> 120 beats per minute, or complicated with malignant arrhythmia;
• Significant coronary artery disease requiring PCI revascularization;
• Severe renal insufficiency (serum creatinine \> 442 μmol/L) or patients on dialysis;

Sponsors & Collaborators

• The First Affiliated Hospital of Air Force Medicial University: lead

Study Sites (1)

The First Affiliated Hospital of Air Force Medical University

Xi’an, Shanxi, China

Location

MeSH Terms

Interventions

Fecal Microbiota Transplantation; Capsules

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Chen Yang

CONTACT

029-19959467156; 19959467156@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

CN (1)