Clinical trial NCT02728154: The Role of Gut Microbiota in Heart Failure and Pre-Heart Failure With Preserved Ejection Fraction
Official title: Characterize the Gut Microbiota in Subjects With Heart Failure and Pre-heart Failure With Preserved Ejection Fraction
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Failure
Keywords: pre-clinical diastolic dysfunction (pre-HFpEF)
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2016-04-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consenting participants who have normal, diastolic dysfunction or heart failure

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.

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

Primary outcomes:
measure: Stool sample for fecal microbiota between the groups
timeFrame: Day 1
Secondary outcomes:
measure: Blood samples for inflammatory cytokines between the groups
timeFrame: Day 1
measure: Blood samples for SAA between the groups
timeFrame: Day 1
measure: Blood samples for inflammatory cells between the groups
timeFrame: Day 1
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Cardiovascular Clinic at UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Carl J Pepine, MD
role: PRINCIPAL_INVESTIGATOR
References: