MedPath

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

Recruiting
Conditions
Heart Failure
Interventions
Other: Blood Sample
Other: Stool Sample
Registration Number
NCT02728154
Lead Sponsor
University of Florida
Brief Summary

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.

Detailed 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
220
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
Read More
Exclusion Criteria
  • intestinal surgery,
  • inflammatory bowel disease,
  • celiac disease,
  • lactose intolerance,
  • chronic pancreatitis or
  • other malabsorption disorder
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Normal controlStool SampleThe subjects in the normal heart function group will provide a blood sample and stool sample.
Normal controlBlood SampleThe subjects in the normal heart function group will provide a blood sample and stool sample.
heart failureBlood SampleThe subjects in history of heart failure group will provide a blood sample and stool sample.
heart failureStool SampleThe subjects in history of heart failure group will provide a blood sample and stool sample.
pre-HFpEFStool SampleThe subjects in history of diastolic dysfunction but not had heart failure clinical presentations group will provide a blood sample and stool sample.
pre-HFpEFBlood SampleThe subjects in history of diastolic dysfunction but not had heart failure clinical presentations group will provide a blood sample and stool sample.
Primary Outcome Measures
NameTimeMethod
Stool sample for fecal microbiota between the groupsDay 1

Stool samples will be collected to compare the fecal microbiota of subjects with normal, diastolic heart dysfunction before heart failure developed and heart failure.

Secondary Outcome Measures
NameTimeMethod
Blood samples for inflammatory cytokines between the groupsDay 1

Blood samples will be used to compare difference in inflammatory cytokines including Interleukin-1 (IL-1), 6, 17 between groups using ELISA kits.

Blood samples for inflammatory cells between the groupsDay 1

Blood samples will be used for difference in progenitor/inflammatory cells between the groups.

Blood samples for SAA between the groupsDay 1

Blood samples will be used to compare difference in serum amyloid (SAA) a between groups using ELISA kits.

Trial Locations

Locations (1)

Cardiovascular Clinic at UF Health

🇺🇸

Gainesville, Florida, United States

© Copyright 2025. All Rights Reserved by MedPath