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Clinical Trials/NCT07687212
NCT07687212Not yet recruitingPhase 1

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

The First Affiliated Hospital of Air Force Medicial University1 site in 1 country162 target enrollmentStarted: July 1, 2026Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Not yet recruiting
Sponsor
Enrollment
162
Locations
1
Primary Endpoint
Kansas City Cardiomyopathy Questionnaire (KCCQ)scale score
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •1. Age over 60 years; 2.Relevant investigations within 6 months meet diagnostic criteria for HFpEF:
  • •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;
  • •at least one of the following conditions is met: 1) LVMI>=115 g/m^2(male)or 95 g/m^2(female); 2) LAVI>34 ml/m^2; 3) Relative wall thickness>0.42;or left ventricular free wall thickness>12mm; 4) E/e'>=14; 5) Ventricular septal e'<7cm/s, or lateral wall e'<10cm/s, or mean e'<8cm/s; 6) Tricuspid regurgitant velocity>2.8m/s, or pulmonary artery systolic pressure>35mmHg; 3.NYHA class II to III for cardiac function;
  • •not taking SGLT-2 inhibitors within 6 months before enrollment;
  • •no probiotic preparations taken within 3 months before enrollment;
  • •The current anti-HF Therapeutic Regimen is well tolerated by patients and is stable for at least 1 month;
  • •Currently stable HF with no acute exacerbations;
  • •Cognitive Functioning is basically normal with comprehensible assessment scale content;
  • •possess basic behavioral ability, being able to perform daily activities independently or with the help of accessory aids;
  • •Understand the purpose of the Clinical Study, voluntarily participate and sign informed consent.

Exclusion Criteria

  • •1. the patient's symptoms are due to noncardiac disease;
  • •In those with contraindications to Henggliflozin:
  • •those who are allergic to henggliflozin;
  • •severe renal impairment (eGFR<30ml/min/1.73m^2), end-stage renal disease, or those requiring dialysis;
  • •In those with contraindications to probiotics:
  • •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.
  • •Patients with congenital or acquired immune deficiency.
  • •Those recently treated with high-risk immunosuppression or cytotoxic drugs: e.g., continued use of rituximab, doxorubicin, or a medium-to high-dose steroid hormone (20 mg/d prednisone or higher) for more than 4 weeks.
  • •Severe immunosuppression: Neutrophils <1 500/mm^
  • •had a myocardial infarction within 6 months before enrollment, had a coronary artery bypass graft procedure, or had any event that could reduce LVEF (unless an LVEF >=50%) confirmed;
  • •valve replacement surgery within 6 months before enrollment; 6.Poor blood pressure control (SBP>=180mmHg or DBP>=100 mmHg);
  • •Current acute decompensated heart failure requires treatment;
  • •Resting heart rate exceeding 120 beats/min, or complicated by malignant Arrhythmia;
  • •Significant coronary artery lesions require PCI revascularization;
  • •Severe renal insufficiency (blood creatinine, Cr >442μmol/L) or receiving dialysis treatment;
  • •Patients with urinary tract infection at entry; symptoms and signs of urinary tract infection, such as urinary tract irritation signs (frequent urination, painful urination, urgency), pain and tenderness above the pubic bone, fever, pain or percussion pain in the waist, etc., and urine bacterial culture colony counts >=105/ml;
  • •currently having a malignancy that requires treatment;
  • •Current concurrent acute disease or acute exacerbation of chronic disease; 14.Participated in other interventional investigators within 3 months.

Outcomes

Primary Outcomes

Kansas City Cardiomyopathy Questionnaire (KCCQ)scale score

Time Frame: Baseline, Week 4, Week 8,Week 12

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.

Secondary Outcomes

  • NYHA functional classification(Baseline, Week 4, Week 8,Week 12)
  • 6-Minute Walk Test (6MWT) Distance(Baseline, Week 4, Week 8, Week 12)
  • Serum N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) Level(Baseline, Week 4, Week 8,Week 12)
  • Basic Activities of Daily Living (BADL) Scale Score(Baseline, Week 4, Week 8, Week 12)
  • Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total Score(Baseline, Week 4, Week 8,Week 12)
  • Serum Inflammatory Biomarkers (NLRP3, IL-1β, TNF-α, IL-6, MCP-1, ICAM-1, VCAM-1)(Baseline, Week 4, Week 8, Week 12)
  • Gut Microbiota Composition and Diversity(Baseline, Week 4, Week 8, Week 12)
  • Frailty Status Using the Fried Frailty Phenotype Criteria(Baseline, Week 4, Week 8, Week 12)
  • Nutritional Status Using the Mini Nutritional Assessment (MNA) Scale(Baseline, Week 4, Week 8, Week 12)
  • SARC-F Scale Score(Baseline, Week 4, Week 8, Week 12)
  • Fecal Short Chain Fatty Acids (SCFAs)(Baseline, Week 12)
  • Serum Trimethylamine-N Oxide (TMAO)(Baseline, Week 12)
  • Serum Bile Acids Profile(Baseline, Week 12)
  • White Blood Cell (WBC) Count(Baseline, Week 12)
  • Hemoglobin (HGB) Concentration(Baseline, Week 12)
  • Platelet (PLT) Count(Baseline, Week 12)
  • Serum Creatinine(Baseline, Week 12)
  • Estimated Glomerular Filtration Rate (eGFR)(Baseline, Week 12)
  • Alanine Aminotransferase (ALT)(Baseline, Week 12)
  • Aspartate Aminotransferase (AST)(Baseline, Week 12)
  • Fasting Blood Glucose(Baseline, Week 12)
  • Serum Electrolytes (Sodium, Potassium, Chloride)(Baseline, Week 12)
  • Left Atrial Volume Index (LAVI)(Baseline, Week 12)
  • Left Ventricular Mass Index (LVMI)(Baseline, Week 12)
  • Pulmonary Artery Systolic Pressure (PASP)(Baseline, Week 12)
  • E/e' Ratio(Baseline, Week 12)
  • Total Body Fat Mass(Baseline, Week 12)

Investigators

Sponsor
The First Affiliated Hospital of Air Force Medicial University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ji Chenyang

postgraduate student

The First Affiliated Hospital of Air Force Medicial University

Study Sites (1)

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