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

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ClinicalTrials.gov Identifier: NCT02728154
Recruitment Status : Recruiting
First Posted : April 5, 2016
Last Update Posted : August 10, 2020
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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