About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Henggliflozin Combined with Probiotics
- Henggliflozin
- double placebo