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Clinical Trials/NCT02728154
NCT02728154
Withdrawn
Not Applicable

Characterize the Gut Microbiota in Subjects With Heart Failure and Pre-heart Failure With Preserved Ejection Fraction

University of Florida1 site in 1 country220 target enrollmentOctober 2016
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
University of Florida
Enrollment
220
Locations
1
Primary Endpoint
Stool sample for fecal microbiota between the groups
Status
Withdrawn
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
June 8, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Stool sample for fecal microbiota between the groups

Time Frame: Day 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 Outcomes

  • Blood samples for inflammatory cytokines between the groups(Day 1)
  • Blood samples for inflammatory cells between the groups(Day 1)
  • Blood samples for SAA between the groups(Day 1)

Study Sites (1)

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