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

University of Florida

Status: Withdrawn

Conditions: Heart Failure

Treatments: Other: Blood Sample; Other: Stool Sample

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02728154

IRB201600380 - N

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

• intestinal surgery,
• inflammatory bowel disease,
• celiac disease,
• lactose intolerance,
• chronic pancreatitis or
• other malabsorption disorder

Trial design

0 participants in 3 patient groups

Normal control

Description:

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

Treatment:

Other: Stool Sample

Other: Blood Sample

heart failure

Description:

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

Treatment:

Other: Stool Sample

Other: Blood Sample

pre-HFpEF

Description:

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

Treatment:

Other: Stool Sample

Other: Blood Sample