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Could a gut bacteria transplant ease heart failure in seniors?

NCT ID NCT07628777

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether transplanting healthy gut bacteria (fecal microbiota transplantation) can improve quality of life and exercise ability in elderly patients with a common type of heart failure (HFpEF). Fifty adults aged 60 and older will receive either the transplant or a placebo, while continuing standard heart failure care. The main goal is to see if the treatment boosts heart-related well-being after 20 weeks.

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 50 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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.Aged ≥ 60 years old; * 2.Meeting the diagnostic criteria for HFpEF: 1. Consistent with the epidemiological and demographic characteristics of HFpEF patients; 2. Presence of clinical symptoms and/or signs of heart failure; 3. Cardiac imaging examination indicating LVEF ≥ 50%; 4. In sinus rhythm: BNP ≥ 35 pg/ml and/or NT-proBNP ≥ 125 pg/ml;In atrial fibrillation: BNP ≥ 105 pg/ml and/or NT-proBNP ≥ 365 pg/ml; 5. Meet at least one of the following conditions: 1. LVMI ≥ 115 g/m² (male) or ≥ 95 g/m² (female); 2. LAVI \> 34 ml/m²; 3. Relative wall thickness \> 0.42, or left ventricular free wall thickness \> 12 mm; 4. Septal e' \< 7 cm/s, or lateral e' \< 10 cm/s, or average E/e' ≥ 14; 5. Tricuspid regurgitation velocity \> 2.8 m/s, or pulmonary artery systolic pressure \> 35 mmHg; * 3.NYHA functional class Ⅱ-Ⅲ; * 4.Complicated with metabolic diseases such as hypertension, diabetes and obesity; * 5.Accompanied by gastrointestinal symptoms; * 6.Well-tolerated to current anti-heart failure regimens with stable medication for at least 1 month; * 7.Stable heart failure condition without acute exacerbation; * 8.Basically normal cognitive function, capable of understanding scale assessment contents; * 9.Able to perform daily activities independently; * 10.Fully understanding the purpose of this clinical trial, voluntary participation and signing of written informed consent. Exclusion Criteria: * 1.Symptoms caused by non-cardiac diseases; * 2.Patients with any contraindication to Fecal Microbiota Transplantation (FMT): 1. Patients with severe intestinal barrier damage induced by various causes, such as sepsis, active massive gastrointestinal bleeding, intestinal perforation; 2. Patients diagnosed with fulminant colitis or toxic megacolon; 3. Patients unable to tolerate enteral nutrition meeting 50% of calorie requirements due to severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinal hemorrhage, high-output intestinal fistula and other conditions; 4. Patients with congenital or acquired immunodeficiency diseases; 5. Patients receiving high-risk immunosuppressive or cytotoxic drugs recently, such as rituximab, doxorubicin, or moderate-to-high dose steroids (prednisone ≥ 20 mg/d) administered continuously for more than 4 weeks; 6. Severely immunosuppressed patients with neutrophil count \< 1500/mm³; * 3.History of myocardial infarction, coronary artery bypass grafting, or any event that may reduce LVEF within 6 months before enrollment (unless LVEF ≥ 50% was confirmed); * 4.Received valve replacement surgery within 6 months before enrollment; * 5.Poorly controlled blood pressure (SBP ≥ 180 mmHg or DBP ≥ 100 mmHg); * 6.Current acute decompensated heart failure requiring intervention; * 7.Resting heart rate \> 120 beats per minute, or complicated with malignant arrhythmia; * 8.Significant coronary artery disease requiring PCI revascularization; * 9.Severe renal insufficiency (serum creatinine \> 442 μmol/L) or patients on dialysis; * 10.Pre-existing gastrointestinal diseases, including ulcerative colitis, Crohn's disease, irritable bowel syndrome, chronic diarrhea; * 11.Current malignant tumors requiring anti-tumor treatment; * 12.Complicated with acute diseases or acute exacerbation of chronic diseases at present; * 13.Participation in other interventional clinical trials or oral intake of probiotic preparations within the past 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

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Contacts and locations

Locations

  • The First Affiliated Hospital of Air Force Medical University

    Xi’an, Shanxi, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.