Heart FailureNCT02728154
The Role of Gut Microbiota in Heart Failure and Pre-Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure, run by University of Florida at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Blood Sample and Stool Sample
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 8 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consenting participants who have normal, diastolic dysfunction or heart failure
Who may be able to join
- 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
Who cannot join
- intestinal surgery,
- inflammatory bowel disease,
- celiac disease,
- lactose intolerance,
- chronic pancreatitis or
- other malabsorption disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Clinic at UF Health
Gainesville, Florida, 32610
About this study
Official title: Characterize the Gut Microbiota in Subjects With Heart Failure and Pre-heart Failure With Preserved Ejection Fraction
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Blood Sample, Stool Sample
- Keywords
- pre-clinical diastolic dysfunction (pre-HFpEF)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SampleOther
One tablespoon of blood will be drawn once during the study.
Stool SampleOther
One stool sample will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Normal control | The subjects in the normal heart function group will provide a blood sample and stool sample. Receives: Other: Blood Sample; Other: Stool Sample | |
| heart failure | The subjects in history of heart failure group will provide a blood sample and stool sample. Receives: 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. Receives: Other: Blood Sample; Other: Stool Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (3)
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.
Measured: Day 1
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.
Measured: Day 1
Blood samples for inflammatory cells between the groups
Blood samples will be used for difference in progenitor/inflammatory cells between the groups.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startOct 2016
- Primary completion8 Jun 2025 (estimated)
- Study completion8 Jun 2025 (estimated)
Why it stopped: No study participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carl J Pepine, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728154
- Sponsor's protocol ID
- IRB201600380 - N
- Status last verified
- Apr 2025
- First submitted
- 30 Mar 2016
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterize the Gut Microbiota in Subjects With Heart Failure and Pre-heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT02728154
- Acronym / sponsor ID
- IRB201600380 - N
- Conditions
- Heart Failure
- Keywords
- pre-clinical diastolic dysfunction (pre-HFpEF)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No study participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 8 Jun 2025 (estimated)
- Study completion
- 8 Jun 2025 (estimated)
- First posted
- 5 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal control | – | Other: Blood Sample, Other: Stool SampleThe subjects in the normal heart function group will provide a blood sample and stool sample. |
| heart failure | – | Other: Blood Sample, Other: Stool SampleThe subjects in history of heart failure group will provide a blood sample and stool sample. |
| pre-HFpEF | – | Other: Blood Sample, Other: Stool SampleThe subjects in history of diastolic dysfunction but not had heart failure clinical presentations group will provide a blood sample and stool sample. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consenting participants who have normal, diastolic dysfunction or heart failure
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- intestinal surgery,
- inflammatory bowel disease,
- celiac disease,
- lactose intolerance,
- chronic pancreatitis or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood SampleOne tablespoon of blood will be drawn once during the study. | Other | Normal control, heart failure, pre-HFpEF |
| Stool SampleOne stool sample will be collected. | Other | Normal control, heart failure, pre-HFpEF |
Primary outcome
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.
3 secondary outcomes
Blood samples for inflammatory cytokines between the groups
Time frame: Day 1
Blood samples for SAA between the groups
Time frame: Day 1
Blood samples for inflammatory cells between the groups
Time frame: Day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure
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The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
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Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl J Pepine, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool sample for fecal microbiota between the groups (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.