Correlation of Intestinal Flora and Metabolomics in Patients With Ischemic Heart Failure

July 4, 2021 updated by: Peking University Third Hospital

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Heart Failure Inclusion Criteria:

  1. Age ≥18;
  2. A clear diagnosis of coronary heart disease;
  3. NYHA cardiac function grade ≥III and/or LVEF≤40%;
  4. Voluntarily signed the informed consent.

Control Inclusion Criteria:

  1. The spouse of the case group;
  2. Age ≥18;
  3. No previous clear diagnosis of coronary heart disease;
  4. The LVEF: 50 ~ 80%;
  5. Voluntarily signed the informed consent.

Exclusion Criteria:

  1. Have received major gastrointestinal surgery (including gallbladder and appendectomy) within 5 years;
  2. Inflammatory bowel disease (IBD), including ulcerative colitis, Crohn's disease, or colitis;
  3. Acute gastroenteritis;
  4. Clostridium difficile (recurrent) or Helicobacter pylori infection;
  5. Persistent or chronic diarrhea;
  6. Chronic constipation;
  7. Peptic ulcer;
  8. Polyps in the stomach or intestines;
  9. Gastrointestinal neoplasms;
  10. Irritable bowel syndrome;
  11. Acute or chronic cholecystitis, hepatitis;
  12. Take or inject antibiotics and probiotics in the past 3 months
  13. End-stage disease (life expectancy less than 3 months);
  14. Pregnant or pregnant during follow-up;
  15. Failure to give informed consent (e.g. severe cognitive impairment);
  16. The patient has been enrolled in other ongoing clinical trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Control
Heart Failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the end of enrollment to six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Study Director: Lei Li, Doctor, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2021

Primary Completion (Anticipated)

May 30, 2022

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

July 4, 2021

First Submitted That Met QC Criteria

July 4, 2021

First Posted (Actual)

July 15, 2021

Study Record Updates

Last Update Posted (Actual)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 4, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LM2021230

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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