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

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