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Heart Failure With Preserved Ejection Fraction (HFPEF)Phase 1/2NCT07628777

Fecal Microbiota Transplantation for Elderly Patients With HFpEF: A Randomized Controlled Trial

A Phase 1/2 study testing Fecal Microbiota Transplantation (FMT) Capsules in people with Heart Failure With Preserved Ejection Fraction (HFPEF) and Chronic Heart Failure, run by The First Affiliated Hospital of Air Force Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a single-center, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) in elderly patients with heart failure with preserved ejection fraction (HFpEF). Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Fecal Microbiota Transplantation (FMT) Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteChina
Study dates
Jun 2026to 31 Dec 2028
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.Aged ≥ 60 years old;
  • 2.Meeting the diagnostic criteria for HFpEF:
  • Consistent with the epidemiological and demographic characteristics of HFpEF patients;
  • Presence of clinical symptoms and/or signs of heart failure;
  • Cardiac imaging examination indicating LVEF ≥ 50%;
  • 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;
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  • Meet at least one of the following conditions:
  • LVMI ≥ 115 g/m² (male) or ≥ 95 g/m² (female);
  • LAVI > 34 ml/m²;
  • Relative wall thickness > 0.42, or left ventricular free wall thickness > 12 mm;
  • Septal e' < 7 cm/s, or lateral e' < 10 cm/s, or average E/e' ≥ 14;
  • 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.

Who cannot join

  • 1.Symptoms caused by non-cardiac diseases;
  • 2.Patients with any contraindication to Fecal Microbiota Transplantation (FMT):
  • Patients with severe intestinal barrier damage induced by various causes, such as sepsis, active massive gastrointestinal bleeding, intestinal perforation;
  • Patients diagnosed with fulminant colitis or toxic megacolon;
  • 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;
  • Patients with congenital or acquired immunodeficiency diseases;
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  • 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;
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chen Yang contact

029-19959467156

19959467156@163.com

China1 site

  • The First Affiliated Hospital of Air Force Medical University

    Xi’an, Shanxi

    Chen Yang, 029-19959467156, 19959467156@163.com

Other trials in China

About this study

Official title: Fecal Microbiota Transplantation for Elderly Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Controlled Trial

This is a single-center, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) in elderly patients with heart failure with preserved ejection fraction (HFpEF).

HFpEF is a common type of heart failure in older adults, often associated with poor quality of life and frequent hospitalizations. Recent research suggests that changes in gut bacteria may contribute to the progression of HFpEF. FMT aims to restore a healthy gut microbiome, which may improve heart function and reduce symptoms.

Read more

Participants will be randomly assigned to receive either FMT or a placebo treatment. The primary goal is to compare changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score between the two groups at 20 weeks. Secondary goals include assessing improvements in exercise capacity (6-minute walk test), NYHA functional class, and safety outcomes.

The study will enroll 50 elderly patients (aged ≥60 years) with confirmed HFpEF. All participants will receive standard medical care for HFpEF throughout the study. This trial is sponsored by The First Affiliated Hospital of Air Force Medical University and conducted in accordance with ethical standards.

Being tested
Fecal Microbiota Transplantation (FMT) Capsules, Placebo capsules
Keywords
Heart Failure with Preserved Ejection Fraction, HFpEF, Fecal Microbiota Transplantation, FMT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fecal Microbiota Transplantation (FMT) CapsulesBiological

    Bowel preparation with polyethylene glycol (PEG) before treatment, followed by oral administration of fecal microbiota transplantation (FMT) capsules. Patients will receive standard HFpEF medical care throughout the study.

  • Placebo capsulesBiological

    Bowel preparation with polyethylene glycol (PEG) before treatment, followed by oral administration of identical-appearing placebo capsules. Patients will receive standard HFpEF medical care throughout the study.

Study groups in NCT07628777
Study groupRoleWhat they receive
Fecal Microbiota Transplantation (FMT) GroupExperimentalNot described
Receives: Biological: Fecal Microbiota Transplantation (FMT) Capsules
Placebo Control GroupPlacebo comparatorNot described
Receives: Biological: Placebo capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score from Baseline to Week 20

    The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a validated patient-reported outcome measure assessing heart failure-specific quality of life. The change in the overall summary score from baseline to week 20 will be compared between the FMT group and the placebo group. Higher scores indicate better health status.

    Measured: Baseline, Week 4, Week 20

Secondary outcomes (33)

  1. Change in NYHA Functional Class from Baseline to Week 20

    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 20 will be compared between groups.

    Measured: Baseline, Week 4, Week 20

  2. Change in 6-Minute Walk Test (6MWT) Distance from Baseline to Week 20

    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, and week 20 to evaluate changes in exercise tolerance.

    Measured: Baseline, Week 4, Week 20

  3. Change in Serum N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) Level from Baseline to Week 20

    Serum NT-proBNP is a key biomarker for heart failure severity. Levels will be measured at baseline, week 4, and week 20 to assess changes in cardiac strain.

    Measured: Baseline, Week 4, Week 20

  4. Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total Score from Baseline to Week 20

    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 20 will be compared.

    Measured: Baseline, Week 4, Week 20

  5. Change in Serum Inflammatory Biomarkers (NLRP3, IL-1β, TNF-α, IL-6, MCP-1, ICAM-1, VCAM-1) from Baseline to Week 20

    Serum levels of the following inflammatory and endothelial activation markers (all units: pg/mL) will be measured to assess the effect of FMT 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 20

  6. Change in Gut Microbiota Composition and Diversity from Baseline to Week 20

    Fecal samples will be collected for 16S rRNA sequencing to analyze changes in gut microbiota composition, diversity, and taxonomic profiles following FMT intervention.

    Measured: Baseline, Week 20

  7. Change in Serum Nitric Oxide (NO) Level from Baseline to Week 20

    Serum nitric oxide (NO) concentration will be measured as an indicator of vascular endothelial function.

    Measured: Baseline, Week 4, Week 20

  8. Change in Frailty Status Using the Fried Frailty Phenotype Criteria from Baseline to Week 20

    Frailty status will be assessed using the Fried criteria to evaluate changes in physical vulnerability.

    Measured: Baseline, Week 20

  9. Change in Nutritional Status Using the Mini Nutritional Assessment (MNA) Scale from Baseline to Week 20

    Nutritional status will be evaluated using the Mini Nutritional Assessment (MNA) scale. Changes in total score from baseline to week 20 will be compared.

    Measured: Baseline, Week 20

  10. Change in Basic Activities of Daily Living (BADL) Scale Score from Baseline to Week 20

    The Basic Activities of Daily Living (BADL) scale will be used to assess changes in patients' functional independence in daily activities.

    Measured: Baseline, Week 20

  11. Change in SARC-F Scale Score from Baseline to Week 20

    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 20 will be evaluated.

    Measured: Baseline, Week 20

  12. Change in Fecal Short-Chain Fatty Acids (SCFAs) from Baseline to Week 20

    Concentrations of fecal short-chain fatty acids (including acetate, propionate, and butyrate) will be quantified (unit: μmol/g) to assess changes in gut microbial fermentation.

    Measured: Baseline, Week 20

  13. Change in Serum Trimethylamine N-Oxide (TMAO) from Baseline to Week 20

    Serum TMAO level will be measured (unit: μM) as a marker of gut microbiota-dependent metabolism of dietary phosphatidylcholine and carnitine.

    Measured: Baseline, Week 20

  14. Change in Serum Bile Acids Profile from Baseline to Week 20

    Serum concentrations of primary and secondary bile acids (e.g., cholic acid, deoxycholic acid) will be quantified (unit: μM) to evaluate changes in bile acid metabolism.

    Measured: Baseline, Week 20

  15. Change in Serum Indole-3-Propionate (IPA) from Baseline to Week 20

    Serum IPA level will be measured (unit: μM) as a gut microbiota-derived tryptophan metabolite.

    Measured: Baseline, Week 20

  16. Change in Serum Indoxyl Sulfate from Baseline to Week 20

    Serum indoxyl sulfate level will be quantified (unit: μM) as a representative gut microbiota-derived uremic toxin.

    Measured: Baseline, Week 20

  17. Change in White Blood Cell (WBC) Count from Baseline to Week 20

    WBC count will be measured (unit: ×10⁹/L) to monitor changes in systemic inflammatory/immune status.

    Measured: Baseline, Week 4, Week 20

  18. Change in Hemoglobin (HGB) Concentration from Baseline to Week 20

    Hemoglobin concentration will be measured (unit: g/L) to assess changes in oxygen-carrying capacity.

    Measured: Baseline, Week 4, Week 20

  19. Change in Platelet (PLT) Count from Baseline to Week 20

    Platelet count will be measured (unit: ×10⁹/L) to evaluate changes in hemostatic/thrombotic potential.

    Measured: Baseline, Week 4, Week 20

  20. Change in Serum Creatinine from Baseline to Week 20

    Serum creatinine level will be measured (unit: μmol/L) to assess renal function.

    Measured: Baseline, Week 4, Week 20

  21. Change in Estimated Glomerular Filtration Rate (eGFR) from Baseline to Week 20

    eGFR will be calculated (unit: mL/min/1.73m²) as a marker of renal function.

    Measured: Baseline, Week 4, Week 20

  22. Change in Alanine Aminotransferase (ALT) from Baseline to Week 20

    Serum ALT level will be measured (unit: U/L) to assess hepatocellular integrity.

    Measured: Baseline, Week 4, Week 20

  23. Change in Aspartate Aminotransferase (AST) from Baseline to Week 20

    Serum AST level will be measured (unit: U/L) to assess hepatocellular integrity.

    Measured: Baseline, Week 4, Week 20

  24. Change in Fasting Blood Glucose from Baseline to Week 20

    Fasting blood glucose concentration will be measured (unit: mmol/L) to assess glycemic status.

    Measured: Baseline, Week 4, Week 20

  25. Change in Serum Electrolytes (Sodium, Potassium, Chloride) from Baseline to Week 20

    Serum concentrations of sodium (Na⁺), potassium (K⁺), and chloride (Cl-) will be measured (all units: mmol/L). Each electrolyte will be analyzed separately for changes from baseline.

    Measured: Baseline, Week 4, Week 20

  26. Change in Left Atrial Volume Index (LAVI) from Baseline to Week 20

    LAVI (unit: mL/m²) will be measured to assess changes in left atrial remodeling.

    Measured: Baseline, Week 4, Week 20

  27. Change in Left Ventricular Mass Index (LVMI) from Baseline to Week 20

    LVMI (unit: g/m²) will be measured to assess changes in left ventricular hypertrophy.

    Measured: Baseline, Week 4, Week 20

  28. Change in Pulmonary Artery Systolic Pressure (PASP) from Baseline to Week 20

    PASP (unit: mmHg) will be measured to assess changes in pulmonary artery pressure.

    Measured: Baseline, Week 4, Week 20

  29. Change in E/e' Ratio from Baseline to Week 20

    The E/e' ratio (unitless) will be measured to assess changes in left ventricular filling pressure.

    Measured: Baseline, Week 4, Week 20

  30. Change in Serum Diamine Oxidase (DAO) from Baseline to Week 20

    Serum DAO level (unit: U/L) will be measured to assess changes in intestinal barrier integrity.

    Measured: Baseline, Week 4, Week 20

  31. Change in Serum D-Lactate from Baseline to Week 20

    Serum D-lactate level (unit: μmol/L) will be measured to assess changes in intestinal permeability.

    Measured: Baseline, Week 4, Week 20

  32. Change in Serum Endotoxin from Baseline to Week 20

    Serum endotoxin level (unit: EU/mL) will be measured to assess changes in bacterial translocation and intestinal barrier function.

    Measured: Baseline, Week 4, Week 20

  33. Change in Total Body Fat Mass from Baseline to Week 20

    Body fat mass will be measured (unit: kg) to assess changes in adiposity.

    Measured: Baseline, Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07628777
Sponsor's protocol ID
KY20252186-F-1
Status last verified
Jun 2026
First submitted
24 May 2026
Last updated
5 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Fecal Microbiota Transplantation (FMT) Capsules in people with Heart Failure With Preserved Ejection Fraction (HFPEF) and Chronic Heart Failure, 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 20 inclusion and 19 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 5 Jun 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 Chen Yang (029-19959467156, 19959467156@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score from Baseline to Week 20 (time frame: Baseline, Week 4, Week 20). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07628777.

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 5 Jun 2026.

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