The Role of Gut Microbiota in Heart Failure and Pre-Heart Failure With Preserved Ejection Fraction

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2025-06-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Gut microbiota play an important role in normal cardiovascular function and pathophysiology of cardiovascular diseases. Patients with heart failure (HF) have substantial hemodynamic changes which lead to intestinal hypoperfusion and congestion and eventually change gut morphology, permeability, function and composition of gut microbiota and cause translocation of microbial and endotoxins into the blood stream. Additionally, metabolites derived from gut microbiota modulate the pathophysiology of HF. Patients with HF have intestinal overgrowth of pathogenic bacteria and increased gut permeability. Accumulating evidence demonstrates that antibiotic treatment benefits patients with acute coronary syndromes and reduces the incidence of ischemic cardiovascular events. Taking the strong association of gut microbiota with HF into account, it is reasonable to speculate that gut microbiota could contribute to the progression of pre-HF with preserved ejection fraction (pre-HFpEF) to HF with preserved ejection fraction (HFpEF). Pre-HFpEF remains poorly understood, yet has high prevalence and a significantly high risk for death in comparison to patient without pre-HFpEF. We hypothesize that altered gut microbiota is involved in the initiation and establishment of HF and pre-HFpEF.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Gut Microbiome Profiling in Patients With Chronic Heart Failure

NCT06361524

Heart Failure With Reduced Ejection Fraction Nonischemic Cardiomyopathy

ENROLLING_BY_INVITATION

The Gut Microbiota and Metabolites in HFpEF

NCT06645535

HFpEF - Heart Failure With Preserved Ejection Fraction

ENROLLING_BY_INVITATION

Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction

NCT06517186

Heart Failure Heart Failure With Preserved Ejection Fraction

RECRUITING

Cardiometabolic evalUation REgistry of Heart Failure

NCT06939985

Heart Failure Metabolic Cardiovascular Syndrome Metabolic Diseases

RECRUITING

Impact of a Letter Encouraging Pneumococcal Vaccination on the 1-year Vaccination Rate in Heart Failure Patients With a Primary Care Physician

NCT06360315

Chronic Heart Failure

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The research study will initially enroll 50 subjects without HF as normal controls,120 subjects with history of HF and 50 subjects with pre-HFpEF to characterize gut microbiota. The subjects will provide blood samples and a stool sample.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normal control

The subjects in the normal heart function group will provide a blood sample and stool sample.

Blood Sample

Intervention Type OTHER

One tablespoon of blood will be drawn once during the study.

Stool Sample

Intervention Type OTHER

One stool sample will be collected.

heart failure

The subjects in history of heart failure group will provide a blood sample and stool sample.

Blood Sample

Intervention Type OTHER

One tablespoon of blood will be drawn once during the study.

Stool Sample

Intervention Type OTHER

One stool sample will be collected.

pre-HFpEF

The subjects in history of diastolic dysfunction but not had heart failure clinical presentations group will provide a blood sample and stool sample.

Blood Sample

Intervention Type OTHER

One tablespoon of blood will be drawn once during the study.

Stool Sample

Intervention Type OTHER

One stool sample will be collected.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood Sample

One tablespoon of blood will be drawn once during the study.

Intervention Type OTHER

Stool Sample

One stool sample will be collected.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Competent and willing to provide consent
* Control subjects with normal heart function
* Subjects with history of HF
* Subjects with impaired ventricular relaxation and/or elevated left ventricular end diastolic pressure measured by echocardiography and/or catheterization, yet has not had HF clinical presentations