Heart Failure With Reduced Ejection FractionNCT06361524
Gut Microbiome Profiling in Patients With Chronic Heart Failure
An observational study of Heart Failure With Reduced Ejection Fraction and Nonischemic Cardiomyopathy, run by Stanford University at 1 site in United States.
Trial summary
The goal of this observational study is to learn about the composition and function of the gut microbiome in adults with chronic heart failure with reduced ejection fraction. The main questions the study aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, Nonischemic Cardiomyopathy
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults diagnosed with heart failure with reduced ejection fraction due to non-ischemic cardiomyopathy will be recruited from outpatient cardiomyopathy/heart failure clinic.
Who may be able to join
- Heart failure with reduced ejection fraction (left ventricular ejection fraction less than 50%)
- Non-ischemic cardiomyopathy
- Body mass index (BMI) 18-40 kg/m2
Who cannot join
- Treated diabetes
- Advanced kidney disease
- Cirrhosis
- Significant gastrointestinal disease including any history of inflammatory bowel disease
- History of extensive bowel resection
- Active malignancy or systemic chemotherapy within the past 12 months
Show all 9Show fewer
- Active infection
- Current or recent (within 4 weeks) use of systemic antibiotics, commercial probiotics, immunosuppressive or immunomodulatory medications
- Pregnancy/lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford University
Stanford, California, 94305-5210
About this study
Official title: Longitudinal Gut Microbiome and Host Multi-omic Profiling in Patients With Chronic Heart Failure
The goal of this observational study is to learn about the composition and function of the gut microbiome in adults with chronic heart failure with reduced ejection fraction. The main questions the study aims to answer are:
- How does the gut microbiome and its interactions with the host change over time in adults with chronic heart failure?
- How do these changes relate to heart failure disease severity and complications?
Read the detailed description
During this study, investigators will recruit adults diagnosed with chronic heart failure with reduced ejection fraction caused by non-ischemic cardiomyopathy. These individuals will undergo longitudinal profiling. This will include detailed profiling of their (1) gut microbiome, (2) blood metabolic and immune markers, and (3) heart failure clinical status. Integrated results will lead to deeper understanding of how gut microbiome interacts with and affects the host in chronic heart failure.
- Keywords
- Gut microbiome, Gut microbiota, Heart failure, Nonischemic Cardiomyopathy, Multiomics
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure | Adults with heart failure with reduced ejection fraction; no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advanced heart failure-associated microbiome signatures
A map of gut microbiome compositional and functional features associated with a composite clinical outcome of advanced heart failure (composite of needing heart transplantation (including active listing), left ventricular assist device implantation, transition to hospice, or death) that occurs within 24 months of baseline visit. Fecal samples will be collected every 3 months over the first 12 month period. Microbiota composition will be determined by shotgun metagenomic sequencing, with taxonomic and metabolic pathway signatures generated using bioinformatic pipelines, respectively. Comprehensive microbiome signatures will encompass alpha and beta diversity, and differential abundance analysis.
Measured: 24 months from baseline visit
Temporal changes in the gut microbiome community composition in chronic heart failure
Longitudinal changes in the gut microbiome composition and functionality in chronic heart failure will be determined. Microbiome signatures will be mapped from fecal samples collected every 3 months over a 12 month period, generated from shotgun metagenomic sequencing data and after processing through bioinformatic pipelines.
Measured: 12 months from baseline visit
Secondary outcomes (4)
Comprehensive longitudinal metabolome profile in chronic heart failure
Changes in the host (human) metabolome profile in chronic heart failure with reduced ejection fraction will be determined. Participants provide fasting blood samples every 3 months for 12 months, from which plasma samples are prepared. Plasma metabolites are run through liquid chromatography-mass spectrometry (LC-MS) columns. MetID (Metabolite Identification from a reference database) and our LC-MS data are used to identify hundreds of metabolites with confidence levels 1-2. Many of the identified metabolites are gut microbiome-derived.
Measured: 12 months from baseline visit
Comprehensive longitudinal cytokine profile in chronic heart failure
Changes in the host (human) cytokines in chronic heart failure with reduced ejection fraction will be determined. Participants provide fasting blood samples every 3 months for 12 months, from which serum samples are prepared. Cytokines are profiled using a 76-cytokine Luminex profiling system at the Stanford Human Immune Monitoring Center. This involves attaching antibodies specific to cytokines to beads using a capture molecule. The fluorescent molecules are attached to the cytokines, and fluorescence is used as the measure of cytokine abundance.
Measured: 12 months from baseline visit
Longitudinal change in New York Heart Association (NYHA) functional class
Participants' functional status (as measured by NYHA class, which ranges from 1 to 4, with 1 being no to minimal symptoms with activity, and 4 being symptoms at rest) will be assessed at each study visit for the first 12 months (every 3 months).
Measured: 12 months from baseline visit
Longitudinal change in the self-reported functional status
Participant self-reported functional status will be assessed via Kansas City Cardiomyopathy Questionnaire-12, which participant will complete at each study visit (every 3 months for 12 months). Overall summary and clinical summary scores (each 0-100, with 0 corresponding to severe and 100 corresponding to no functional limitations) will be calculated and compared over visits.
Measured: 12 months from baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 Aug 2018
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), American Heart Association
- Responsible party
- Principal investigator, Petra Mamic, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361524
- Sponsor's protocol ID
- 44967
- Other IDs
- 5F32HL143916, 856341
- Status last verified
- May 2025
- First submitted
- 5 Apr 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified clinical data, gut microbiome (taxonomic and metabolic pathway) profiles, plasma metabolome and cytokines (see details below), in addition to analytical code
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Gut Microbiome and Host Multi-omic Profiling in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT06361524
- Acronym / sponsor ID
- 44967
- Keywords
- Gut microbiome, Gut microbiota, Heart failure, Nonischemic Cardiomyopathy, Multiomics
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), American Heart Association
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Apr 2024 (actual)
- 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.
The goal of this observational study is to learn about the composition and function of the gut microbiome in adults with chronic heart failure with reduced ejection fraction. The main questions the study aims to answer are:
- How does the gut microbiome and its interactions with the host change over time in adults with chronic heart failure?
- How do these changes relate to heart failure disease severity and complications?
Detailed description
During this study, investigators will recruit adults diagnosed with chronic heart failure with reduced ejection fraction caused by non-ischemic cardiomyopathy. These individuals will undergo longitudinal profiling. This will include detailed profiling of their (1) gut microbiome, (2) blood metabolic and immune markers, and (3) heart failure clinical status. Integrated results will lead to deeper understanding of how gut microbiome interacts with and affects the host in chronic heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure | – | –Adults with heart failure with reduced ejection fraction; no intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with heart failure with reduced ejection fraction due to non-ischemic cardiomyopathy will be recruited from outpatient cardiomyopathy/heart failure clinic.
Key inclusion criteria (3 listed)
- Heart failure with reduced ejection fraction (left ventricular ejection fraction less than 50%)
- Non-ischemic cardiomyopathy
- Body mass index (BMI) 18-40 kg/m2
Key exclusion criteria (9 listed)
- Treated diabetes
- Advanced kidney disease
- Cirrhosis
- Significant gastrointestinal disease including any history of inflammatory bowel disease
- History of extensive bowel resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Advanced heart failure-associated microbiome signatures
Time frame: 24 months from baseline visit
A map of gut microbiome compositional and functional features associated with a composite clinical outcome of advanced heart failure (composite of needing heart transplantation (including active listing), left ventricular assist device implantation, transition to hospice, or death) that occurs within 24 months of baseline visit. Fecal samples will be collected every 3 months over the first 12 month period. Microbiota composition will be determined by shotgun metagenomic sequencing, with taxonomic and metabolic pathway signatures generated using bioinformatic pipelines, respectively. Comprehensive microbiome signatures will encompass alpha and beta diversity, and differential abundance analysis.
Temporal changes in the gut microbiome community composition in chronic heart failure
Time frame: 12 months from baseline visit
Longitudinal changes in the gut microbiome composition and functionality in chronic heart failure will be determined. Microbiome signatures will be mapped from fecal samples collected every 3 months over a 12 month period, generated from shotgun metagenomic sequencing data and after processing through bioinformatic pipelines.
4 secondary outcomes
Comprehensive longitudinal metabolome profile in chronic heart failure
Time frame: 12 months from baseline visit
Comprehensive longitudinal cytokine profile in chronic heart failure
Time frame: 12 months from baseline visit
Longitudinal change in New York Heart Association (NYHA) functional class
Time frame: 12 months from baseline visit
Longitudinal change in the self-reported functional status
Time frame: 12 months from baseline visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: Yes. De-identified clinical data, gut microbiome (taxonomic and metabolic pathway) profiles, plasma metabolome and cytokines (see details below), in addition to analytical code
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 With Reduced Ejection Fraction and Nonischemic Cardiomyopathy, run by Stanford University 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 3 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 16 May 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?
This study is still under way. Results are not available in the source record yet.
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?
Advanced heart failure-associated microbiome signatures (time frame: 24 months from baseline visit). The study lists 2 primary outcomes in all. 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 16 May 2025.