Heart failure hope: gut bacteria and drug combo tested in seniors
NCT ID NCT07687212
First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time
Summary
This study tests whether adding a combination of an SGLT-2 inhibitor (henagliflozin) and a probiotic to standard heart failure treatment can improve heart function and quality of life in people over 60 with a specific type of heart failure called HFpEF. The trial randomly assigns 162 participants to receive either the drug plus probiotic, the drug alone, or a placebo for 12 weeks. Researchers will measure changes in heart failure symptoms, exercise ability, and markers of inflammation and gut health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Henagliflozin (SGLT-2 inhibitor) and probiotic (clostridial enterococcus triple live tablet)
- What this could lead to
- If successful, this combination could offer a new, more effective treatment for elderly patients with HFpEF, potentially improving heart function, exercise tolerance, and quality of life.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not be conclusive. The combination may not provide additional benefit over standard therapy, and probiotics could cause digestive side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 162 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Age over 60 years; 2.Relevant investigations within 6 months meet diagnostic criteria for HFpEF: 1. epidemiologic and population characteristics of patients with HFpEF; 2. presence of symptoms and/or signs of heart failure; 3. Cardiac imaging suggests LVEF \>=50%; 4. 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; 5. 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. Exclusion Criteria: * 1\. the patient's symptoms are due to noncardiac disease; 2. In those with contraindications to Henggliflozin: 1. those who are allergic to henggliflozin; 2. severe renal impairment (eGFR\<30ml/min/1.73m\^2), end-stage renal disease, or those requiring dialysis; 3. In those with contraindications to probiotics: <!-- --> 1. Patients with severe impairment of the intestinal barrier associated with sepsis, active massive bleeding from the digestive tract, perforation, and other causes. 2. those with current diagnosis of fulminant colitis or toxic megacolon. 3. Enteral feeding that cannot tolerate 50% caloric requirement due to severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinal bleeding, high-flow intestinal fistula, etc. 4. Patients with congenital or acquired immune deficiency. 5. 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. 6. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, China
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Other studies related to the condition(s) this trial covers.
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