A Phase 1/2 interventional study of Fecal Microbiota Transplantation (FMT) Capsules and Placebo capsules in Heart Failure With Preserved Ejection Fraction (HFPEF) and Chronic Heart Failure, sponsored by The First Affiliated Hospital of Air Force Medicial University. Not yet recruiting at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by The First Affiliated Hospital of Air Force Medicial University · Phase 1/2, Interventional, and Treatment
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.
The First Affiliated Hospital of Air Force Medicial University is the lead sponsor of 7 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
2.Meeting the diagnostic criteria for HFpEF:
Meet at least one of the following conditions:
Exclusion Criteria:
2.Patients with any contraindication to Fecal Microbiota Transplantation (FMT):
Biological: Fecal Microbiota Transplantation (FMT) Capsules
Biological: Placebo 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.
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.
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.
Time frame: Baseline, Week 4, Week 20
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.
Time frame: Baseline, Week 4, Week 20
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.
Time frame: Baseline, Week 4, Week 20
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.
Time frame: Baseline, Week 4, Week 20
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.
Time frame: 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
Serum levels of the following inflammatory and endothelial activation markers (all units: pg/mL) will be measured to assess the effect of FMT on systemic inflammation in patients with HFpEF: NLRP3, IL-1β, TNF-α, IL-6, MCP-1, ICAM-1, and VCAM-1. Each biomarker will be analyzed separately for changes from baseline.
Time frame: Baseline, Week 4, Week 20
Change in Gut Microbiota Composition and Diversity from Baseline to Week 20
Fecal samples will be collected for 16S rRNA sequencing to analyze changes in gut microbiota composition, diversity, and taxonomic profiles following FMT intervention.
Time frame: Baseline, Week 20
Change in Serum Nitric Oxide (NO) Level from Baseline to Week 20
Serum nitric oxide (NO) concentration will be measured as an indicator of vascular endothelial function.
Time frame: Baseline, Week 4, Week 20
Change in Frailty Status Using the Fried Frailty Phenotype Criteria from Baseline to Week 20
Frailty status will be assessed using the Fried criteria to evaluate changes in physical vulnerability.
Time frame: Baseline, Week 20
Change in Nutritional Status Using the Mini Nutritional Assessment (MNA) Scale from Baseline to Week 20
Nutritional status will be evaluated using the Mini Nutritional Assessment (MNA) scale. Changes in total score from baseline to week 20 will be compared.
Time frame: Baseline, Week 20
Change in Basic Activities of Daily Living (BADL) Scale Score from Baseline to Week 20
The Basic Activities of Daily Living (BADL) scale will be used to assess changes in patients' functional independence in daily activities.
Time frame: Baseline, Week 20
Change in SARC-F Scale Score from Baseline to Week 20
The SARC-F questionnaire is a validated tool for sarcopenia screening, assessing strength, assistance with walking, rising from a chair, climbing stairs, and falls. Changes in total score from baseline to week 20 will be evaluated.
Time frame: Baseline, Week 20
Change in Fecal Short-Chain Fatty Acids (SCFAs) from Baseline to Week 20
Concentrations of fecal short-chain fatty acids (including acetate, propionate, and butyrate) will be quantified (unit: μmol/g) to assess changes in gut microbial fermentation.
Time frame: Baseline, Week 20
Change in Serum Trimethylamine N-Oxide (TMAO) from Baseline to Week 20
Serum TMAO level will be measured (unit: μM) as a marker of gut microbiota-dependent metabolism of dietary phosphatidylcholine and carnitine.
Time frame: Baseline, Week 20
Change in Serum Bile Acids Profile from Baseline to Week 20
Serum concentrations of primary and secondary bile acids (e.g., cholic acid, deoxycholic acid) will be quantified (unit: μM) to evaluate changes in bile acid metabolism.
Time frame: Baseline, Week 20
Change in Serum Indole-3-Propionate (IPA) from Baseline to Week 20
Serum IPA level will be measured (unit: μM) as a gut microbiota-derived tryptophan metabolite.
Time frame: Baseline, Week 20
Change in Serum Indoxyl Sulfate from Baseline to Week 20
Serum indoxyl sulfate level will be quantified (unit: μM) as a representative gut microbiota-derived uremic toxin.
Time frame: Baseline, Week 20
Change in White Blood Cell (WBC) Count from Baseline to Week 20
WBC count will be measured (unit: ×10⁹/L) to monitor changes in systemic inflammatory/immune status.
Time frame: Baseline, Week 4, Week 20
Change in Hemoglobin (HGB) Concentration from Baseline to Week 20
Hemoglobin concentration will be measured (unit: g/L) to assess changes in oxygen-carrying capacity.
Time frame: Baseline, Week 4, Week 20
Change in Platelet (PLT) Count from Baseline to Week 20
Platelet count will be measured (unit: ×10⁹/L) to evaluate changes in hemostatic/thrombotic potential.
Time frame: Baseline, Week 4, Week 20
Change in Serum Creatinine from Baseline to Week 20
Serum creatinine level will be measured (unit: μmol/L) to assess renal function.
Time frame: Baseline, Week 4, Week 20
Change in Estimated Glomerular Filtration Rate (eGFR) from Baseline to Week 20
eGFR will be calculated (unit: mL/min/1.73m²) as a marker of renal function.
Time frame: Baseline, Week 4, Week 20
Change in Alanine Aminotransferase (ALT) from Baseline to Week 20
Serum ALT level will be measured (unit: U/L) to assess hepatocellular integrity.
Time frame: Baseline, Week 4, Week 20
Change in Aspartate Aminotransferase (AST) from Baseline to Week 20
Serum AST level will be measured (unit: U/L) to assess hepatocellular integrity.
Time frame: Baseline, Week 4, Week 20
Change in Fasting Blood Glucose from Baseline to Week 20
Fasting blood glucose concentration will be measured (unit: mmol/L) to assess glycemic status.
Time frame: Baseline, Week 4, Week 20
Change in Serum Electrolytes (Sodium, Potassium, Chloride) from Baseline to Week 20
Serum concentrations of sodium (Na⁺), potassium (K⁺), and chloride (Cl-) will be measured (all units: mmol/L). Each electrolyte will be analyzed separately for changes from baseline.
Time frame: Baseline, Week 4, Week 20
Change in Left Atrial Volume Index (LAVI) from Baseline to Week 20
LAVI (unit: mL/m²) will be measured to assess changes in left atrial remodeling.
Time frame: Baseline, Week 4, Week 20
Change in Left Ventricular Mass Index (LVMI) from Baseline to Week 20
LVMI (unit: g/m²) will be measured to assess changes in left ventricular hypertrophy.
Time frame: Baseline, Week 4, Week 20
Change in Pulmonary Artery Systolic Pressure (PASP) from Baseline to Week 20
PASP (unit: mmHg) will be measured to assess changes in pulmonary artery pressure.
Time frame: Baseline, Week 4, Week 20
Change in E/e' Ratio from Baseline to Week 20
The E/e' ratio (unitless) will be measured to assess changes in left ventricular filling pressure.
Time frame: Baseline, Week 4, Week 20
Change in Serum Diamine Oxidase (DAO) from Baseline to Week 20
Serum DAO level (unit: U/L) will be measured to assess changes in intestinal barrier integrity.
Time frame: Baseline, Week 4, Week 20
Change in Serum D-Lactate from Baseline to Week 20
Serum D-lactate level (unit: μmol/L) will be measured to assess changes in intestinal permeability.
Time frame: Baseline, Week 4, Week 20
Change in Serum Endotoxin from Baseline to Week 20
Serum endotoxin level (unit: EU/mL) will be measured to assess changes in bacterial translocation and intestinal barrier function.
Time frame: Baseline, Week 4, Week 20
Change in Total Body Fat Mass from Baseline to Week 20
Body fat mass will be measured (unit: kg) to assess changes in adiposity.
Time frame: Baseline, Week 20
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The First Affiliated Hospital of Air Force Medicial University