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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02728154
• Other study ID #: IRB201600380 - N
• Secondary ID: 5R01HL132448
• Status: Recruiting
• Start date: October 2016
• Est. completion date: June 8, 2025

Study information

• Verified date: November 2023
• Source: University of Florida
• Contact: Dana Leach, PhD
• Phone: 352-273-8944
• Email: Dana.Leach[@]medicine.ufl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: June 8, 2025
• Est. primary completion date: June 8, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Blood Sample
One tablespoon of blood will be drawn once during the study.
• Stool Sample
One stool sample will be collected.

Locations

Country	Name	City	State
United States	Cardiovascular Clinic at UF Health	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool sample for fecal microbiota between the groups	Stool samples will be collected to compare the fecal microbiota of subjects with normal, diastolic heart dysfunction before heart failure developed and heart failure.	Day 1
Secondary	Blood samples for inflammatory cytokines between the groups	Blood samples will be used to compare difference in inflammatory cytokines including Interleukin-1 (IL-1), 6, 17 between groups using ELISA kits.	Day 1
Secondary	Blood samples for SAA between the groups	Blood samples will be used to compare difference in serum amyloid (SAA) a between groups using ELISA kits.	Day 1
Secondary	Blood samples for inflammatory cells between the groups	Blood samples will be used for difference in progenitor/inflammatory cells between the groups.	Day 1