Gut Microbiome Profiling in Patients With Chronic Heart Failure

NCT06361524 | Enrolling By Invitation

• 3 other identifiers: 449675F32HL143916856341
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the composition and function of the gut microbiome in adults with chronic heart failure with reduced ejection fraction. The main questions the study aims to answer are:

1. 1.How does the gut microbiome and its interactions with the host change over time in adults with chronic heart failure?
2. 2.How do these changes relate to heart failure disease severity and complications?

Conditions

Heart Failure With Reduced Ejection Fraction; Nonischemic Cardiomyopathy

Keywords

Gut microbiome; Gut microbiota; Heart failure; Nonischemic Cardiomyopathy; Multiomics

Outcome Measures

Primary Outcomes (2)

• Advanced heart failure-associated microbiome signatures

  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.

  24 months from baseline visit

• Temporal changes in the gut microbiome community composition in chronic heart failure

  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.

  12 months from baseline visit

Secondary Outcomes (4)

• Comprehensive longitudinal metabolome profile in chronic heart failure

  12 months from baseline visit

• Comprehensive longitudinal cytokine profile in chronic heart failure

  12 months from baseline visit

• Longitudinal change in New York Heart Association (NYHA) functional class

  12 months from baseline visit

• Longitudinal change in the self-reported functional status

  12 months from baseline visit

Study Arms (1)

Heart failure

Adults with heart failure with reduced ejection fraction; no intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults diagnosed with heart failure with reduced ejection fraction due to non-ischemic cardiomyopathy will be recruited from outpatient cardiomyopathy/heart failure clinic.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• American Heart Association: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305-5210, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples, fasting plasma and serum

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 12, 2024
• Study Start: August 1, 2018
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Immediately upon publication, without end date
• Access Criteria: All nucleic acid raw read and processed data will be deposited in Sequence Read Archive (SRA) (metagenomics). Metabolomics and cytokine data will be deposited in Metabolomics Workbench and ImmPort (both of these are National Institutes of Health (NIH) data repositories), respectively. All genomic data sharing will be done in accordance with NIH policies, including the Genomic Data Sharing Policy, and the Institutional Review Board (IRB) approved consent types for each sample type. Detailed metadata will be associated with each dataset. To request access of the data, researchers will use the standard processes at the above repositories. The standard data access processes typically allow access for one year and are renewable. Once the data are submitted to the above repositories, those archive will control the long-term persistence of the data set.

Locations

US (1)