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

NCT02728154 | Withdrawn

• 1 other identifier: IRB201600380 - N
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

pre-clinical diastolic dysfunction (pre-HFpEF)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Blood samples for inflammatory cytokines between the groups

  Day 1

• Blood samples for SAA between the groups

  Day 1

• Blood samples for inflammatory cells between the groups

  Day 1

Study Arms (3)

Normal control

The subjects in the normal heart function group will provide a blood sample and stool sample.

Other: Blood Sample; Other: Stool Sample

heart failure

The subjects in history of heart failure group will provide a blood sample and stool sample.

Other: Blood Sample; Other: Stool Sample

pre-HFpEF

The subjects in history of diastolic dysfunction but not had heart failure clinical presentations group will provide a blood sample and stool sample.

Other: Blood Sample; Other: Stool Sample

Interventions

Blood Sample OTHER

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

Normal control; heart failure; pre-HFpEF

Stool Sample OTHER

One stool sample will be collected.

Normal control; heart failure; pre-HFpEF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consenting participants who have normal, diastolic dysfunction or heart failure

You may qualify if:

• 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

You may not qualify if:

• intestinal surgery,
• inflammatory bowel disease,
• celiac disease,
• lactose intolerance,
• chronic pancreatitis or
• other malabsorption disorder

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Cardiovascular Clinic at UF Health

Gainesville, Florida, 32610, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and stool samples

MeSH Terms

Conditions

Heart Failure

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Carl J Pepine, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 5, 2016
• Study Start: October 1, 2016
• Primary Completion: June 8, 2025
• Study Completion: June 8, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

US (1)