Skip to content

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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02728154
Enrollment
0
Registered
2016-04-05
Start date
2016-10-31
Completion date
2025-06-08
Last updated
2025-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

pre-clinical diastolic dysfunction (pre-HFpEF)

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.

Interventions

OTHERBlood Sample

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

OTHERStool Sample

One stool sample will be collected.

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Stool sample for fecal microbiota between the groupsDay 1Stool samples will be collected to compare the fecal microbiota of subjects with normal, diastolic heart dysfunction before heart failure developed and heart failure.

Secondary

MeasureTime frameDescription
Blood samples for inflammatory cytokines between the groupsDay 1Blood 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 SAA between the groupsDay 1Blood samples will be used to compare difference in serum amyloid (SAA) a between groups using ELISA kits.
Blood samples for inflammatory cells between the groupsDay 1Blood samples will be used for difference in progenitor/inflammatory cells between the groups.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026