Could a gut bacteria transplant ease heart failure in seniors?
NCT ID NCT07628777
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.
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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 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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.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.
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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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Implanted device aims to ease heart failure symptoms
- Can a traditional chinese medicine injection ease heart failure symptoms?
- Team-Based care may cut hospital readmissions for a common heart failure
- Stomach suturing may lighten the load on failing hearts
- Can a once-daily pill ease the burden of a common heart failure?
- A gentle electric pulse to the heart: new device tested for heart failure