Heart Failure, Preserved Ejection FractionPhase 1/2NCT07687212
Randomized Double-blind Controlled Clinical Study of SGLT-2i Combined With Probiotic Preparations in Elderly Patients With HFpEF
A Phase 1/2 study testing Henggliflozin Combined with Probiotics and Henggliflozin in people with Heart Failure, Preserved Ejection Fraction, run by The First Affiliated Hospital of Air Force Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Failure, Preserved Ejection Fraction
- What is being tested?
- Henggliflozin Combined with Probiotics and Henggliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to Nov 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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; 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.
Who cannot join
- 1. 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:
- <!-- -->
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi
The First Affiliated Hospital of Air Force Medical University, +86 15591423352, 3260126173@qq.com
About this study
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.
- Being tested
- Henggliflozin Combined with Probiotics, Henggliflozin, double placebo
- Keywords
- heart failure with preserved ejection fraction，HFpEF, Henggliflozin, Probiotics
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Henggliflozin Combined with ProbioticsDrug
Primary anti-HF therapy + Henagliflozin Proline Tablets (10mg, 1 times/day) + clostridial enterococcus triple live tablet (400mg, 3 times/day) orally, for 12 weeks.
HenggliflozinDrug
Primary anti-HF therapy + Henagliflozin Proline Tablets (10mg, 1 times/day) + placebo (400mg, 3 times/day) orally, for 12 weeks.
double placeboDrug
Primary anti-HF therapy +Two types of placebo tablets orally, for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Henggliflozin Combined with Probiotics Group | Experimental | Not described Receives: Drug: Henggliflozin Combined with Probiotics |
| Henggliflozin Monotherapy Group | Experimental | Not described Receives: Drug: Henggliflozin |
| double placebo group | Placebo comparator | Not described Receives: Drug: double placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4, Week 8,Week 12
Secondary outcomes (27)
NYHA functional classification
The New York Heart Association (NYHA) functional classification is used to assess the severity of heart failure symptoms. Changes in NYHA class from baseline to Week 12 will be compared between groups.
Measured: Baseline, Week 4, Week 8,Week 12
6-Minute Walk Test (6MWT) Distance
The 6-minute walk test is a measure of functional capacity in patients with heart failure. The distance walked in 6 minutes will be assessed at baseline, Week 4, Week 8,and Week 12 to evaluate changes in exercise tolerance.
Measured: Baseline, Week 4, Week 8, Week 12
Serum N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) Level
Serum NT-proBNP is a key biomarker for heart failure severity. Levels will be measured at baseline, Week 4, Week 8, and Week 12 to assess changes in cardiac strain.
Measured: Baseline, Week 4, Week 8,Week 12
Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total Score
The MLHFQ is a patient-reported questionnaire evaluating the impact of heart failure on quality of life. Higher scores indicate greater impairment. Changes from baseline to Week 12 will be compared.
Measured: Baseline, Week 4, Week 8,Week 12
Serum Inflammatory Biomarkers (NLRP3, IL-1β, TNF-α, IL-6, MCP-1, ICAM-1, VCAM-1)
Serum levels of the following inflammatory and endothelial activation markers will be measured to assess the effect of drugs on systemic inflammation in patients with HFpEF: NLRP3, IL-1β, TNF-α, IL-6, MCP-1, ICAM-1, and VCAM-1. Each biomarker will be analyzed separately for changes from baseline.
Measured: Baseline, Week 4, Week 8, Week 12
Gut Microbiota Composition and Diversity
Fecal samples will be collected for 16S rRNA sequencing to analyze changes in gut microbiota composition, diversity, and taxonomic profiles following drugs intervention.
Measured: Baseline, Week 4, Week 8, Week 12
Frailty Status Using the Fried Frailty Phenotype Criteria
Frailty status will be assessed using the Fried criteria to evaluate changes in physical vulnerability.
Measured: Baseline, Week 4, Week 8, Week 12
Nutritional Status Using the Mini Nutritional Assessment (MNA) Scale
Nutritional status will be evaluated using the Mini Nutritional Assessment (MNA) scale. Changes in total score from baseline to Week 12 will be compared.
Measured: Baseline, Week 4, Week 8, Week 12
Basic Activities of Daily Living (BADL) Scale Score
The BADL scale will be used to assess changes in patients' functional independence in daily activities.
Measured: Baseline, Week 4, Week 8, Week 12
SARC-F Scale Score
The SARC-F questionnaire is a validated tool for sarcopenia screening, assessing strength, assistance with walking, rising from a chair, climbing stairs, and falls. Changes in total score from baseline to Week 12 will be evaluated.
Measured: Baseline, Week 4, Week 8, Week 12
Fecal Short Chain Fatty Acids (SCFAs)
Concentrations of fecal short-chain fatty acids, including acetate, propionate, and butyrate, will be quantified to assess changes in gut microbial fermentation.
Measured: Baseline, Week 12
Serum Trimethylamine-N Oxide (TMAO)
Serum TMAO levels will be measured as a marker of gut microbiota-dependent metabolism of dietary phosphatidylcholine and carnitine.
Measured: Baseline, Week 12
Serum Bile Acids Profile
Concentrations of primary and secondary bile acids, such as cholic acid and deoxycholic acid, will be quantified to evaluate changes in bile acid metabolism.
Measured: Baseline, Week 12
White Blood Cell (WBC) Count
WBC count will be measured to monitor changes in systemic inflammatory/immune status.
Measured: Baseline, Week 12
Hemoglobin (HGB) Concentration
Hemoglobin concentration will be measured to assess changes in oxygen-carrying capacity.
Measured: Baseline, Week 12
Platelet (PLT) Count
Platelet count will be measured to evaluate changes in hemostatic/thrombotic potential.
Measured: Baseline, Week 12
Serum Creatinine
Serum creatinine level will be measured to assess renal function.
Measured: Baseline, Week 12
Estimated Glomerular Filtration Rate (eGFR)
eGFR will be calculated as a marker of renal function.
Measured: Baseline, Week 12
Alanine Aminotransferase (ALT)
Serum ALT level will be measured to assess hepatocellular integrity.
Measured: Baseline, Week 12
Aspartate Aminotransferase (AST)
Serum AST level will be measured to assess hepatocellular integrity.
Measured: Baseline, Week 12
Fasting Blood Glucose
Fasting blood glucose concentration will be measured to assess glycemic status.
Measured: Baseline, Week 12
Serum Electrolytes (Sodium, Potassium, Chloride)
Serum concentrations of sodium, potassium, and chloride will be measured. Each electrolyte will be analyzed separately for changes from baseline.
Measured: Baseline, Week 12
Left Atrial Volume Index (LAVI)
LAVI will be measured to assess changes in left atrial remodeling.
Measured: Baseline, Week 12
Left Ventricular Mass Index (LVMI)
LVMI will be measured to assess changes in left ventricular hypertrophy.
Measured: Baseline, Week 12
Pulmonary Artery Systolic Pressure (PASP)
PASP will be measured to assess changes in pulmonary artery pressure.
Measured: Baseline, Week 12
E/e' Ratio
The E/e' ratio will be measured to assess changes in left ventricular filling pressure.
Measured: Baseline, Week 12
Total Body Fat Mass
Body fat mass will be measured to assess changes in adiposity.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Air Force Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Chenyang, The First Affiliated Hospital of Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687212
- Sponsor's protocol ID
- KY20262160
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Controlled Clinical Study of SGLT-2i Combined With Probiotic Preparations in Elderly Patients With HFpEF
- ClinicalTrials.gov ID
- NCT07687212
- Acronym / sponsor ID
- KY20262160
- Keywords
- heart failure with preserved ejection fraction，HFpEF, Henggliflozin, Probiotics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Air Force Medical UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Age over 60 years; 2.Relevant investigations within 6 months meet diagnostic criteria for HFpEF:
Key exclusion criteria (10 listed)
- 1. the patient's symptoms are due to noncardiac disease; 2. In those with contraindications to Henggliflozin:
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Henggliflozin Combined with ProbioticsPrimary 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 Combined with Probiotics Group |
| HenggliflozinPrimary anti-HF therapy + Henagliflozin Proline Tablets (10mg, 1 times/day) + placebo (400mg, 3 times/day) orally, for 12 weeks. | Drug | Henggliflozin Monotherapy Group |
| double placeboPrimary anti-HF therapy +Two types of placebo tablets orally, for 12 weeks. | Drug | double placebo group |
Primary outcome
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.
27 secondary outcomes
NYHA functional classification
Time frame: Baseline, Week 4, Week 8,Week 12
6-Minute Walk Test (6MWT) Distance
Time frame: Baseline, Week 4, Week 8, Week 12
Serum N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) Level
Time frame: Baseline, Week 4, Week 8,Week 12
Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total Score
Time frame: Baseline, Week 4, Week 8,Week 12
Serum Inflammatory Biomarkers (NLRP3, IL-1β, TNF-α, IL-6, MCP-1, ICAM-1, VCAM-1)
Time frame: Baseline, Week 4, Week 8, Week 12
Gut Microbiota Composition and Diversity
Time frame: Baseline, Week 4, Week 8, Week 12
Frailty Status Using the Fried Frailty Phenotype Criteria
Time frame: Baseline, Week 4, Week 8, Week 12
Nutritional Status Using the Mini Nutritional Assessment (MNA) Scale
Time frame: Baseline, Week 4, Week 8, Week 12
Basic Activities of Daily Living (BADL) Scale Score
Time frame: Baseline, Week 4, Week 8, Week 12
SARC-F Scale Score
Time frame: Baseline, Week 4, Week 8, Week 12
Fecal Short Chain Fatty Acids (SCFAs)
Time frame: Baseline, Week 12
Serum Trimethylamine-N Oxide (TMAO)
Time frame: Baseline, Week 12
Serum Bile Acids Profile
Time frame: Baseline, Week 12
White Blood Cell (WBC) Count
Time frame: Baseline, Week 12
Hemoglobin (HGB) Concentration
Time frame: Baseline, Week 12
Platelet (PLT) Count
Time frame: Baseline, Week 12
Serum Creatinine
Time frame: Baseline, Week 12
Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline, Week 12
Alanine Aminotransferase (ALT)
Time frame: Baseline, Week 12
Aspartate Aminotransferase (AST)
Time frame: Baseline, Week 12
Fasting Blood Glucose
Time frame: Baseline, Week 12
Serum Electrolytes (Sodium, Potassium, Chloride)
Time frame: Baseline, Week 12
Left Atrial Volume Index (LAVI)
Time frame: Baseline, Week 12
Left Ventricular Mass Index (LVMI)
Time frame: Baseline, Week 12
Pulmonary Artery Systolic Pressure (PASP)
Time frame: Baseline, Week 12
E/e' Ratio
Time frame: Baseline, Week 12
Total Body Fat Mass
Time frame: Baseline, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Henggliflozin Combined with Probiotics and Henggliflozin in people with Heart Failure, Preserved Ejection Fraction, run by The First Affiliated Hospital of Air Force Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JiChenyang (+86 15591423352, 3260126173@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kansas City Cardiomyopathy Questionnaire (KCCQ)scale score (time frame: Baseline, Week 4, Week 8,Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.