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

NCT07687212 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2026-07-07

No results posted yet for this study

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.

Conditions

  • Heart Failure, Preserved Ejection Fraction

Interventions

DRUG

Henggliflozin Combined with Probiotics

Primary anti-HF therapy + Henagliflozin Proline Tablets (10mg, 1 times/day) + clostridial enterococcus triple live tablet (400mg, 3 times/day) orally, for 12 weeks.

DRUG

Henggliflozin

Primary anti-HF therapy + Henagliflozin Proline Tablets (10mg, 1 times/day) + placebo (400mg, 3 times/day) orally, for 12 weeks.

DRUG

double placebo

Primary anti-HF therapy +Two types of placebo tablets orally, for 12 weeks.

Sponsors & Collaborators

  • The First Affiliated Hospital of Air Force Medicial University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-09-30
Completion
2027-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07687212 on ClinicalTrials.gov