To Search for Biomarkers Associated With Ischemic Heart FailureNCT04962763
Correlation of Intestinal Flora and Metabolomics in Patients With Ischemic Heart Failure
An observational study of To Search for Biomarkers Associated With Ischemic Heart Failure and To Explore the Relationship Between Intestinal Flora and Ischemic Heart Failure, run by Peking University Third Hospital at 1 site in China.
Trial summary
To provide new ideas for the treatment of patients with ischemic heart failure, this study is to search for differential metabolic markers associated with ischemic heart failure and to study the influence of fecal flora on the course of heart failure in patients with ischemic heart failure. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- To Search for Biomarkers Associated With Ischemic Heart Failure, To Explore the Relationship Between Intestinal Flora and Ischemic Heart Failure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2021to 30 Apr 2023
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: No intervention. All patients diagnosed with ischemic heart failure in the Third Hospital of Peking University received the current clinical standard treatment plan, and received clinical follow-up and questionnaire survey according to this plan.
Who may be able to join
None listed.
Who cannot join
- Have received major gastrointestinal surgery (including gallbladder and appendectomy) within 5 years;
- Inflammatory bowel disease (IBD), including ulcerative colitis, Crohn's disease, or colitis;
- Acute gastroenteritis;
- Clostridium difficile (recurrent) or Helicobacter pylori infection;
- Persistent or chronic diarrhea;
- Chronic constipation;
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- Peptic ulcer;
- Polyps in the stomach or intestines;
- Gastrointestinal neoplasms;
- Irritable bowel syndrome;
- Acute or chronic cholecystitis, hepatitis;
- Take or inject antibiotics and probiotics in the past 3 months
- End-stage disease (life expectancy less than 3 months);
- Pregnant or pregnant during follow-up;
- Failure to give informed consent (e.g. severe cognitive impairment);
- The patient has been enrolled in other ongoing clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Lei Li, Doctor, 13811089790, dr_lilei@126.com
About this study
Official title: Correlation of Intestinal Flora and Metabolomics in Patients With Ischemic Heart
To provide new ideas for the treatment of patients with ischemic heart failure, this study is to search for differential metabolic markers associated with ischemic heart failure and to study the influence of fecal flora on the course of heart failure in patients with ischemic heart failure.
Read the detailed description
Heart failure (HF) is the final stage of all cardiovascular diseases. Myocardial damage caused by myocardial infarction, cardiomyopathy, hemodynamic overload, inflammation, or any other cause, can result in changes in myocardial structure and function, resulting in ventricular pumping and/or diastolic dysfunction. Among them, ischemic heart disease caused by coronary artery lesions is the primary cause of heart failure, clinically known as ischemic heart failure (IHF).
More and more studies have confirmed that the structure and function of the gut and the substances in the gut play an important role in the pathogenesis of heart failure, and proposed the "gut hypothesis of heart failure". Previous studies have shown that regulation of intestinal flora and its metabolites may improve the progression of patients with heart failure to some extent, but further studies are still needed to explore whether regulation of intestinal flora can effectively delay the development of heart failure and thus improve the prognosis.
This study recruited 150 patients with ischemic heart failure and 50 healthy volunteers matched with age and sex in the heart failure group required by the researchers plan to conventional drug treatment of heart failure, but in front of the collection of serum, stool samples, the patients and healthy volunteers shall be the standard diet, work and rest, time sampling (that is, the timing acquisition participants in the early morning of 2 g feces and 2 mL fasting venous blood).Metabolic profiles of serum and stool samples from patients with ischemic heart failure and healthy volunteers were studied using LC-MS, 1H NMR and 16sRNA based metabolomics and intestinal microbiome methods to identify differential metabolic markers associated with ischemic heart failure. The feces of patients with ischemic heart failure were transplanted into model rats to investigate the regulatory effects of the feces of patients with ischemic heart failure and the feces of healthy volunteers on the structure of intestinal microflora and related metabolism of normal and model animals, so as to systematically study the influence of the fecal microflora of patients with ischemic heart failure on the course of heart failure.
- Conditions
- To Search for Biomarkers Associated With Ischemic Heart Failure, To Explore the Relationship Between Intestinal Flora and Ischemic Heart Failure
- Keywords
- ischemic heart failure, biomarkers, intestinal flora, metabonomics
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 | Not described | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Find a new diagnostic method for ischemic heart failure
Identify biomarkers and differential intestinal flora associated with ischemic heart failure
Measured: From the end of enrollment to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start30 Jun 2021
- Primary completion30 May 2022 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Search for Biomarkers Associated With Ischemic Heart FailureStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Case-control
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Li, Doctor, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962763
- Sponsor's protocol ID
- LM2021230
- Status last verified
- Jul 2021
- First submitted
- 4 Jul 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Intestinal Flora and Metabolomics in Patients With Ischemic Heart
- ClinicalTrials.gov ID
- NCT04962763
- Acronym / sponsor ID
- LM2021230
- Conditions
- To Search for Biomarkers Associated With Ischemic Heart Failure, To Explore the Relationship Between Intestinal Flora and Ischemic Heart Failure
- Keywords
- ischemic heart failure, biomarkers, intestinal flora, metabonomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 15 Jul 2021 (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.
To provide new ideas for the treatment of patients with ischemic heart failure, this study is to search for differential metabolic markers associated with ischemic heart failure and to study the influence of fecal flora on the course of heart failure in patients with ischemic heart failure.
Detailed description
Heart failure (HF) is the final stage of all cardiovascular diseases. Myocardial damage caused by myocardial infarction, cardiomyopathy, hemodynamic overload, inflammation, or any other cause, can result in changes in myocardial structure and function, resulting in ventricular pumping and/or diastolic dysfunction. Among them, ischemic heart disease caused by coronary artery lesions is the primary cause of heart failure, clinically known as ischemic heart failure (IHF).
More and more studies have confirmed that the structure and function of the gut and the substances in the gut play an important role in the pathogenesis of heart failure, and proposed the "gut hypothesis of heart failure". Previous studies have shown that regulation of intestinal flora and its metabolites may improve the progression of patients with heart failure to some extent, but further studies are still needed to explore whether regulation of intestinal flora can effectively delay the development of heart failure and thus improve the prognosis.
This study recruited 150 patients with ischemic heart failure and 50 healthy volunteers matched with age and sex in the heart failure group required by the researchers plan to conventional drug treatment of heart failure, but in front of the collection of serum, stool samples, the patients and healthy volunteers shall be the standard diet, work and rest, time sampling (that is, the timing acquisition participants in the early morning of 2 g feces and 2 mL fasting venous blood).Metabolic profiles of serum and stool samples from patients with ischemic heart failure and healthy volunteers were studied using LC-MS, 1H NMR and 16sRNA based metabolomics and intestinal microbiome methods to identify differential metabolic markers associated with ischemic heart failure. The feces of patients with ischemic heart failure were transplanted into model rats to investigate the regulatory effects of the feces of patients with ischemic heart failure and the feces of healthy volunteers on the structure of intestinal microflora and related metabolism of normal and model animals, so as to systematically study the influence of the fecal microflora of patients with ischemic heart failure on the course of heart failure.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart Failure | – | – |
| Control | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- No intervention. All patients diagnosed with ischemic heart failure in the Third Hospital of Peking University received the current clinical standard treatment plan, and received clinical follow-up and questionnaire survey according to this plan.
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- Have received major gastrointestinal surgery (including gallbladder and appendectomy) within 5 years;
- Inflammatory bowel disease (IBD), including ulcerative colitis, Crohn's disease, or colitis;
- Acute gastroenteritis;
- Clostridium difficile (recurrent) or Helicobacter pylori infection;
- Persistent or chronic diarrhea;
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
Find a new diagnostic method for ischemic heart failure
Time frame: From the end of enrollment to six months
Identify biomarkers and differential intestinal flora associated with ischemic heart failure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Individual participant dataSharing planned: Undecided
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.
Lei Li, Doctor study director
Peking University Third Hospital
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 To Search for Biomarkers Associated With Ischemic Heart Failure and To Explore the Relationship Between Intestinal Flora and Ischemic Heart Failure, run by Peking University Third Hospital at 1 site in China.
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 0 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 15 Jul 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Li, Doctor (13811089790, dr_lilei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Find a new diagnostic method for ischemic heart failure (time frame: From the end of enrollment to six months). 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 15 Jul 2021.