Clinical Trial

Randomized Double-blind Controlled Clinical Study of SGLT-2i Combined With Probiotic Preparations in Elderly Patients With HFpEF

Not Yet Recruiting Phase 1/2
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Summary
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.
Trial Details
NCT Number NCT07687212
Lead Sponsor The First Affiliated Hospital of Air Force Medicial University
Conditions Heart Failure, Preserved Ejection Fraction
Enrollment 162 participants
Start Date 2026-07
Primary Completion 2027-09 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-07