Clinical trial NCT06361524: Gut Microbiome Profiling in Patients With Chronic Heart Failure
Official title: Longitudinal Gut Microbiome and Host Multi-omic Profiling in Patients With Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Heart Failure With Reduced Ejection Fraction
Nonischemic Cardiomyopathy
Keywords: Gut microbiome
Gut microbiota
Heart failure
Nonischemic Cardiomyopathy
Multiomics
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: American Heart Association
First posted: 2024-04-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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. 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.

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

Primary outcomes:
measure: Advanced heart failure-associated microbiome signatures
timeFrame: 24 months from baseline visit
measure: Temporal changes in the gut microbiome community composition in chronic heart failure
timeFrame: 12 months from baseline visit
Secondary outcomes:
measure: Comprehensive longitudinal metabolome profile in chronic heart failure
timeFrame: 12 months from baseline visit
measure: Comprehensive longitudinal cytokine profile in chronic heart failure
timeFrame: 12 months from baseline visit
measure: Longitudinal change in New York Heart Association (NYHA) functional class
timeFrame: 12 months from baseline visit
measure: Longitudinal change in the self-reported functional status
timeFrame: 12 months from baseline visit
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References: