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

NCT07687212 | Not Yet Recruiting Phase 1

• 1 other identifier: KY20262160
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure, Preserved Ejection Fraction

Keywords

heart failure with preserved ejection fraction，HFpEF; Henggliflozin; Probiotics

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 4, Week 8,Week 12

Secondary Outcomes (27)

• 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

• 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

Study Arms (3)

Henggliflozin Combined with Probiotics Group

EXPERIMENTAL

Drug: Henggliflozin Combined with Probiotics

Henggliflozin Monotherapy Group

EXPERIMENTAL

Drug: Henggliflozin

double placebo group

PLACEBO COMPARATOR

Drug: double placebo

Interventions

Henggliflozin Combined with Probiotics DRUG

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

Henggliflozin Combined with Probiotics Group

Henggliflozin DRUG

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

Henggliflozin Monotherapy Group

double placebo DRUG

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

double placebo group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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; 4. not taking SGLT-2 inhibitors within 6 months before enrollment; 5. no probiotic preparations taken within 3 months before enrollment; 6. The current anti-HF Therapeutic Regimen is well tolerated by patients and is stable for at least 1 month; 7. Currently stable HF with no acute exacerbations; 8. Cognitive Functioning is basically normal with comprehensible assessment scale content; 9. possess basic behavioral ability, being able to perform daily activities independently or with the help of accessory aids; 10. Understand the purpose of the Clinical Study, voluntarily participate and sign informed consent.

You may not qualify if:

• \. the patient's symptoms are due to noncardiac disease; 2. 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; 3. In those with contraindications to probiotics:
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• 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\^3. 4. 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; 5. valve replacement surgery within 6 months before enrollment; 6.Poor blood pressure control (SBP\>=180mmHg or DBP\>=100 mmHg); 7. Current acute decompensated heart failure requires treatment; 8. Resting heart rate exceeding 120 beats/min, or complicated by malignant Arrhythmia; 9. Significant coronary artery lesions require PCI revascularization; 10. Severe renal insufficiency (blood creatinine, Cr \>442μmol/L) or receiving dialysis treatment; 11. 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; 12. currently having a malignancy that requires treatment; 13. Current concurrent acute disease or acute exacerbation of chronic disease; 14.Participated in other interventional investigators within 3 months.

Sponsors & Collaborators

• The First Affiliated Hospital of Air Force Medicial University: lead

Study Sites (1)

The First Affiliated Hospital of Air Force Medical University

Xi’an, Shanxi, China

Location

MeSH Terms

Conditions

Heart Failure, Diastolic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

JiChenyang

CONTACT

+86 15591423352; 3260126173@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: postgraduate student

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06

Locations

CN (1)