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HFpEF has a high incidence and lacks effective therapy, and its onset is closely related to systemic inflammation and intestinal dysbacteriosis.SGLT-2i exerts its effects by diuresis, anti-inflammatory and improving energy metabolism, whereas probiotics modulate intestinal flora, reduce inflammatory markers, and regulate immune responses.The combination of the two drugs is not only expected to exert synergistic therapeutic potential, but may also reduce the risk of sarcopenia associated with SGLT-2i weight loss.This study aims to combine henagliflozin and a probiotic preparation on the basis of standard anti-heart-failure therapy, and to observe their effects on cardiac and renal function, intestinal barrier function, quality of life, and exercise tolerance in elderly patients with HFpEF, while exploring the underlying mechanisms, so as to provide new data and therapeutic strategies for the treatment of elderly HFpEF patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Henggliflozin Combined with Probiotics Group | Experimental |
| |
| Henggliflozin Monotherapy Group | Experimental |
| |
| double placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Henggliflozin Combined with Probiotics | Drug | Primary anti-HF therapy + Henagliflozin Proline Tablets (10mg, 1 times/day) + clostridial enterococcus triple live tablet (400mg, 3 times/day) orally, for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Kansas City Cardiomyopathy Questionnaire (KCCQ)scale score | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a validated patient-reported outcome measure used to assess heart failure-specific quality of life. The change in the overall summary score from baseline to Week 12 will be compared between the groups. Higher scores indicate better health status. | Baseline, Week 4, Week 8,Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| NYHA functional classification | The 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 12 will be compared between groups. | Baseline, Week 4, Week 8,Week 12 |
| 6-Minute Walk Test (6MWT) Distance |
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Inclusion Criteria:
1. Age over 60 years; 2.Relevant investigations within 6 months meet diagnostic criteria for HFpEF:
Exclusion Criteria:
1. the patient's symptoms are due to noncardiac disease; 2. In those with contraindications to Henggliflozin:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JiChenyang | Contact | +86 15591423352 | 3260126173@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Air Force Medical University | Xi’an | Shanxi | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 7, 2026 | Jun 30, 2026 |
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| Henggliflozin | Drug | Primary anti-HF therapy + Henagliflozin Proline Tablets (10mg, 1 times/day) + placebo (400mg, 3 times/day) orally, for 12 weeks. |
|
| double placebo | Drug | Primary anti-HF therapy +Two types of placebo tablets orally, for 12 weeks. |
|
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, Week 8,and Week 12 to evaluate changes in exercise tolerance. |
| Baseline, Week 4, Week 8, Week 12 |
| Serum N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) Level | Serum NT-proBNP is a key biomarker for heart failure severity. Levels will be measured at baseline, Week 4, Week 8, and Week 12 to assess changes in cardiac strain. | Baseline, Week 4, Week 8,Week 12 |
| Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total Score | 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 12 will be compared. | Baseline, Week 4, Week 8,Week 12 |
| Serum Inflammatory Biomarkers (NLRP3, IL-1β, TNF-α, IL-6, MCP-1, ICAM-1, VCAM-1) | Serum levels of the following inflammatory and endothelial activation markers will be measured to assess the effect of drugs 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. | Baseline, Week 4, Week 8, Week 12 |
| Gut Microbiota Composition and Diversity | Fecal samples will be collected for 16S rRNA sequencing to analyze changes in gut microbiota composition, diversity, and taxonomic profiles following drugs intervention. | Baseline, Week 4, Week 8, Week 12 |
| Frailty Status Using the Fried Frailty Phenotype Criteria | Frailty status will be assessed using the Fried criteria to evaluate changes in physical vulnerability. | Baseline, Week 4, Week 8, Week 12 |
| Nutritional Status Using the Mini Nutritional Assessment (MNA) Scale | Nutritional status will be evaluated using the Mini Nutritional Assessment (MNA) scale. Changes in total score from baseline to Week 12 will be compared. | Baseline, Week 4, Week 8, Week 12 |
| Basic Activities of Daily Living (BADL) Scale Score | The BADL scale will be used to assess changes in patients' functional independence in daily activities. | Baseline, Week 4, Week 8, Week 12 |
| SARC-F Scale Score | 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 12 will be evaluated. | Baseline, Week 4, Week 8, Week 12 |
| Fecal Short Chain Fatty Acids (SCFAs) | Concentrations of fecal short-chain fatty acids, including acetate, propionate, and butyrate, will be quantified to assess changes in gut microbial fermentation. | Baseline, Week 12 |
| Serum Trimethylamine-N Oxide (TMAO) | Serum TMAO levels will be measured as a marker of gut microbiota-dependent metabolism of dietary phosphatidylcholine and carnitine. | Baseline, Week 12 |
| Serum Bile Acids Profile | Concentrations of primary and secondary bile acids, such as cholic acid and deoxycholic acid, will be quantified to evaluate changes in bile acid metabolism. | Baseline, Week 12 |
| White Blood Cell (WBC) Count | WBC count will be measured to monitor changes in systemic inflammatory/immune status. | Baseline, Week 12 |
| Hemoglobin (HGB) Concentration | Hemoglobin concentration will be measured to assess changes in oxygen-carrying capacity. | Baseline, Week 12 |
| Platelet (PLT) Count | Platelet count will be measured to evaluate changes in hemostatic/thrombotic potential. | Baseline, Week 12 |
| Serum Creatinine | Serum creatinine level will be measured to assess renal function. | Baseline, Week 12 |
| Estimated Glomerular Filtration Rate (eGFR) | eGFR will be calculated as a marker of renal function. | Baseline, Week 12 |
| Alanine Aminotransferase (ALT) | Serum ALT level will be measured to assess hepatocellular integrity. | Baseline, Week 12 |
| Aspartate Aminotransferase (AST) | Serum AST level will be measured to assess hepatocellular integrity. | Baseline, Week 12 |
| Fasting Blood Glucose | Fasting blood glucose concentration will be measured to assess glycemic status. | Baseline, Week 12 |
| Serum Electrolytes (Sodium, Potassium, Chloride) | Serum concentrations of sodium, potassium, and chloride will be measured. Each electrolyte will be analyzed separately for changes from baseline. | Baseline, Week 12 |
| Left Atrial Volume Index (LAVI) | LAVI will be measured to assess changes in left atrial remodeling. | Baseline, Week 12 |
| Left Ventricular Mass Index (LVMI) | LVMI will be measured to assess changes in left ventricular hypertrophy. | Baseline, Week 12 |
| Pulmonary Artery Systolic Pressure (PASP) | PASP will be measured to assess changes in pulmonary artery pressure. | Baseline, Week 12 |
| E/e' Ratio | The E/e' ratio will be measured to assess changes in left ventricular filling pressure. | Baseline, Week 12 |
| Total Body Fat Mass | Body fat mass will be measured to assess changes in adiposity. | Baseline, Week 12 |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 7, 2026 | Jun 30, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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