Gut Microbiome Profiling in Patients With Chronic Heart Failure

Stanford University

Status: Invitation-only

Conditions: Heart Failure With Reduced Ejection Fraction; Nonischemic Cardiomyopathy

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06361524

856341 (Other Grant/Funding Number)

44967

5F32HL143916 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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?

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Heart failure

Description:

Adults with heart failure with reduced ejection fraction; no intervention