Gut Microbiome Profiling in Patients With Chronic Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Failure With Reduced Ejection Fraction, Nonischemic Cardiomyopathy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Longitudinal Gut Microbiome and Host Multi-omic Profiling in Patients With Chronic Heart Failure
Overview
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. How does the gut microbiome and its interactions with the host change over time in adults with chronic heart failure? 2. How do these changes relate to heart failure disease severity and complications?
Detailed description
During this study, investigators will recruit adults diagnosed with chronic heart failure with reduced ejection fraction caused by non-ischemic cardiomyopathy. These individuals will undergo longitudinal profiling. This will include detailed profiling of their (1) gut microbiome, (2) blood metabolic and immune markers, and (3) heart failure clinical status. Integrated results will lead to deeper understanding of how gut microbiome interacts with and affects the host in chronic heart failure.
Primary outcome measures
- Advanced heart failure-associated microbiome signatures [Time frame: 24 months from baseline visit]
- Temporal changes in the gut microbiome community composition in chronic heart failure [Time frame: 12 months from baseline visit]
Secondary outcome measures (4)
- Comprehensive longitudinal metabolome profile in chronic heart failure [Time frame: 12 months from baseline visit]
- Comprehensive longitudinal cytokine profile in chronic heart failure [Time frame: 12 months from baseline visit]
- Longitudinal change in New York Heart Association (NYHA) functional class [Time frame: 12 months from baseline visit]
- Longitudinal change in the self-reported functional status [Time frame: 12 months from baseline visit]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Stanford University — Stanford
Identifiers
NCT: NCT06361524 · 44967 · 5F32HL143916 · 856341