Heart Failure Clinical Trial

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

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.

View Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

220

Study ID:

NCT02728154

Recruitment Status:

Recruiting

Sponsor:

University of Florida

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Cardiovascular Clinic at UF Health
Gainesville Florida, 32610, United States More Info
Eileen M Handberg, PhD
Contact
352-273-8944
[email protected]
Carl J Pepine, MD
Sub-Investigator
Yanfei Qi, PhD
Sub-Investigator
Eileen M Handberg, PhD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

220

Study ID:

NCT02728154

Recruitment Status:

Recruiting

Sponsor:


University of Florida

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.