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

• ClinicalTrials.gov Identifier: NCT02728154
• Recruitment Status: Recruiting
• First Posted: April 5, 2016
• Last Update Posted: August 10, 2020
• Sponsor: University of Florida
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): University of Florida

Tracking Information

• First Submitted Date: March 30, 2016
• First Posted Date: April 5, 2016
• Last Update Posted Date: August 10, 2020
• Actual Study Start Date: October 2016
• Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 30, 2016)

Stool sample for fecal microbiota between the groups [ Time Frame: Day 1 ]

Stool samples will be collected to compare the fecal microbiota of subjects with normal, diastolic heart dysfunction before heart failure developed and heart failure.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 16, 2016)

• Blood samples for inflammatory cytokines between the groups [ Time Frame: Day 1 ]
  Blood 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 groups [ Time Frame: Day 1 ]
  Blood samples will be used to compare difference in serum amyloid (SAA) a between groups using ELISA kits.
• Blood samples for inflammatory cells between the groups [ Time Frame: Day 1 ]
  Blood samples will be used for difference in progenitor/inflammatory cells between the groups.

Original Secondary Outcome Measures (submitted: March 30, 2016)

• Blood samples for biomarkers between the groups [ Time Frame: Day 1 ]
  Blood samples will be used for difference in biomarkers between the groups.
• Blood samples for inflammatory cells between the groups [ Time Frame: Day 1 ]
  Blood samples will be used for difference in progenitor/inflammatory cells between the groups.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Blood and stool samples

• Sampling Method: Non-Probability Sample
• Study Population: Consenting participants who have normal, diastolic dysfunction or heart failure
• Condition: Heart Failure

Intervention

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

Study Groups/Cohorts

• Normal control
  The subjects in the normal heart function group will provide a blood sample and stool sample.
  Interventions:

  • Other: Blood Sample
  • Other: Stool Sample
• heart failure
  The subjects in history of heart failure group will provide a blood sample and stool sample.
  Interventions:

  • 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.
  Interventions:

  • Other: Blood Sample
  • Other: Stool Sample

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 30, 2016): 220
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2021
• Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Dana Leach, PhD; 352-273-8944; Dana.Leach@medicine.ufl.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02728154
• Other Study ID Numbers: IRB201600380 - N; R01HL132448 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: University of Florida
• Study Sponsor: University of Florida
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Carl J Pepine, MD; University of Florida

• PRS Account: University of Florida
• Verification Date: August 2020