Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Heart Failure Other: Blood Sample Other: Stool Sample

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterize the Gut Microbiota in Subjects With Heart Failure and Pre-heart Failure With Preserved Ejection Fraction
Actual Study Start Date : October 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Normal control
The subjects in the normal heart function group will provide a blood sample and stool sample.
 Other: Blood Sample
One tablespoon of blood will be drawn once during the study.

Other: Stool Sample
One stool sample will be collected.
heart failure
The subjects in history of heart failure group will provide a blood sample and stool sample.
 Other: Blood Sample
One tablespoon of blood will be drawn once during the study.

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

Other: Stool Sample
One stool sample will be collected.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Biospecimen Retention:   Samples With DNA
Blood and stool samples

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Consenting participants who have normal, diastolic dysfunction or heart failure
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728154


Contacts
Layout table for location contacts
Contact: Dana Leach, PhD 352-273-8944 Dana.Leach@medicine.ufl.edu

Locations
Layout table for location information
United States, Florida
Cardiovascular Clinic at UF Health Recruiting
Gainesville, Florida, United States, 32610
Contact: Eileen M Handberg, PhD    352-273-8944    handbem@ufl.edu   
Sub-Investigator: Carl J Pepine, MD         
Sub-Investigator: Yanfei Qi, PhD         
Principal Investigator: Eileen M Handberg, PhD         
Sponsors and Collaborators
University of Florida
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: Carl J Pepine, MD University of Florida
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02728154    
Other Study ID Numbers: IRB201600380 - N
R01HL132448 ( U.S. NIH Grant/Contract )
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Florida:
pre-clinical diastolic dysfunction (pre-HFpEF)
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases