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Heart failure hope: gut bacteria and drug combo tested in seniors

NCT ID NCT07687212

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 162 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

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

60 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • 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.