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.
epidemiologic and population characteristics of patients with HFpEF;
presence of symptoms and/or signs of heart failure;
Cardiac imaging suggests LVEF >=50%;
BNP>=35pg/ml and (or) NT-pro BNP>=125pg/ml in sinus rhythm, and BNP>=105pg/ml and (or) NT-pro BNP>=365pg/ml in atrial fibrillation;
those who are allergic to henggliflozin;
Patients with severe impairment of the intestinal barrier associated with sepsis, active massive bleeding from the digestive tract, perforation, and other causes.
those with current diagnosis of fulminant colitis or toxic megacolon.
Enteral feeding that cannot tolerate 50% caloric requirement due to severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinal bleeding, high-flow intestinal fistula, etc.
Parallel
Henggliflozin Combined with Probiotics
DrugPrimary anti-HF therapy + Henagliflozin Proline Tablets (10mg, 1 times/day) + clostridial enterococcus triple live tablet (400mg, 3 times/day) orally, for 12 weeks.
Henggliflozin
DrugPrimary anti-HF therapy + Henagliflozin Proline Tablets (10mg, 1 times/day) + placebo (400mg, 3 times/day) orally, for 12 weeks.
double placebo
DrugPrimary anti-HF therapy +Two types of placebo tablets orally, for 12 weeks.
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.
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.
6-Minute Walk Test (6MWT) Distance
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.
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.
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.
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