Gut Microbiome Profiling in Patients With Chronic Heart Failure

NCT ID: NCT06361524

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure With Reduced Ejection Fraction Nonischemic Cardiomyopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Heart failure

Adults with heart failure with reduced ejection fraction; no intervention

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

American Heart Association

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Petra Mamic

Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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5F32HL143916

Identifier Type: NIH

Identifier Source: secondary_id

View Link

856341

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

44967

Identifier Type: -

Identifier Source: org_study_id

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