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NCT06361524

Gut Microbiome Profiling in Patients With Chronic Heart Failure

Enrolling by Invitation
Not specifiedAges 18–75Observational
Stanford University
~150 participants
Updated 2025-05-16 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Advanced heart failure-associated microbiome signatures
Measured over 24 months from baseline visit
+1 more outcome measured

Conditions

Heart Failure With Reduced Ejection Fraction
Nonischemic Cardiomyopathy

Explore related trials

CardiomyopathyHeart Failure

Where it's being run

1 sites across 1 states
California1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Heart failure with reduced ejection fraction (left ventricular ejection fraction less than 50%)
Non-ischemic cardiomyopathy
Body mass index (BMI) 18-40 kg/m2

Exclusion

Treated diabetes
Advanced kidney disease
Cirrhosis
Significant gastrointestinal disease including any history of inflammatory bowel disease
History of extensive bowel resection
Active malignancy or systemic chemotherapy within the past 12 months
Active infection
Current or recent (within 4 weeks) use of systemic antibiotics, commercial probiotics, immunosuppressive or immunomodulatory medications
Pregnancy/lactation

What this trial measures

  • Advanced heart failure-associated microbiome signatures24 months from baseline visit

    A map of gut microbiome compositional and functional features associated with a composite clinical outcome of advanced heart failure (composite of needing heart transplantation (including active listing), left ventricular assist device implantation, transition to hospice, or death) that occurs within 24 months of baseline visit. Fecal samples will be collected every 3 months over the first 12 month period. Microbiota composition will be determined by shotgun metagenomic sequencing, with taxonomic and metabolic pathway signatures generated using bioinformatic pipelines, respectively. Comprehensive microbiome signatures will encompass alpha and beta diversity, and differential abundance analysis.

  • Temporal changes in the gut microbiome community composition in chronic heart failure12 months from baseline visit

    Longitudinal changes in the gut microbiome composition and functionality in chronic heart failure will be determined. Microbiome signatures will be mapped from fecal samples collected every 3 months over a 12 month period, generated from shotgun metagenomic sequencing data and after processing through bioinformatic pipelines.