Depression and CVDNCT06975592
Study on the Mechanism of Multi-group Analysis of the Influence of Depression on Common Cardiovascular Diseases
An observational study of Depression and CVD, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
Cardiovascular disease is the main cause of death in the world, accounting for 32% of all deaths. In 2019, the number of people suffering from cardiovascular diseases in the world was about 523 million, of which about 18.6 million died of cardiovascular diseases. Read more about this study
- Who is it for?
- Ages Up to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression and CVD
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2025to 1 Jul 2029
- 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 Up to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Samples of feces, urine and peripheral blood were collected from healthy control group, depression group and depression combined with cardiovascular disease group, and were analyzed by multi-omics. Subsequently, the patients were followed up in the outpatient clinic at 6 months, 1 year, 2 years and 5 years after discharge, and the clinical prognosis details of the patients were obtained and recorded.
Who may be able to join
- Healthy control group 1) Good health and no gastrointestinal diseases; 2) No previous history of mental illness; 3) No previous history of cardiovascular disease;
- Depression group
- 1) Meet the diagnostic criteria of the latest guidelines for depression, and be clinically diagnosed by at least two psychiatrists; 2) Patients with first-episode depression; 3) Have not taken any psychoactive drugs before or have not taken any psychoactive drugs within 4 weeks.
- 3. Depression with cardiovascular disease group
- Meet the diagnostic criteria of the latest guidelines for depression, and be clinically diagnosed by at least two psychiatrists;
- Patients with first-episode depression;
- Have not taken any psychoactive drugs before or have not taken any psychoactive drugs within 4 weeks.
- There is definite clinical evidence of heart failure, coronary heart disease, hypertension or arrhythmia.
Who cannot join
- Have a history of alcohol dependence, organic brain diseases, nervous system diseases and other complex mental diseases;
- Long-term use of psychoactive drugs/use of psychoactive drugs within 4 weeks;
- Patients with thyroid dysfunction
- Patients with severe liver and kidney dysfunction;
- Patients with chronic obstructive pulmonary disease, interstitial pulmonary fibrosis and pulmonary hypertension;
- Patients with autoimmune diseases and tumors;
Show all 13Show fewer
- used antibiotics, yogurt or other drugs or foods that affect intestinal flora within 4 weeks;
- Pregnant or lactating women;
- There is a serious impairment of cognitive function, which makes it impossible to cooperate with the research procedure;
- Have received invasive medical procedures such as gastroscopy and colonoscopy in the past three months;
- The diet has changed greatly in the past week;
- Participate in simultaneous clinical trials;
- Refuse to sign the informed consent for participating in the experiment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
About this study
Cardiovascular disease is the main cause of death in the world, accounting for 32% of all deaths. In 2019, the number of people suffering from cardiovascular diseases in the world was about 523 million, of which about 18.6 million died of cardiovascular diseases. Although great progress has been made in reducing the burden of cardiovascular diseases by controlling typical risk factors, there is still a lack of effective intervention means and measures for cardiovascular diseases induced by atypical risk factors (such as environmental pollution, obesity and anxiety and depression).
Depression is a health problem as common as cardiovascular disease, and it has been proved to be an important risk factor of cardiovascular disease. Previous studies have shown that depression is related to the increased risk of subsequent cardiovascular events, including myocardial infarction, angina pectoris, stroke and cardiovascular mortality. The risk of cardiovascular disease in patients with major depression is about 72% higher than that in healthy control group.
Read more
Previous studies have shown that compared with healthy people, the intestinal microbial composition of patients with major depression, especially the microbial diversity and the relative abundance of specific bacterial groups, has changed significantly. Many studies have also confirmed that dysbacteriosis may be an important cause of MDD, and with the passage of time, the pathological changes caused by MDD will further destroy the intestinal environment and lead to dysbacteriosis. In addition, intestinal microflora can also produce a variety of important mediators, such as metabolites produced by bacterial fermentation of food, host molecules modified by bacteria (bile acids, etc.) or direct products of bacteria, which also play an important role in the pathogenesis of MDD. In recent years, both population studies and animal experiments have found that the changes in the composition and function of intestinal flora (that is, the imbalance of intestinal microbial flora) will accelerate the occurrence and development of cardiovascular diseases. Intestinal flora will metabolize the food ingested by the host into a series of metabolites, including trimethylamine oxide, short-chain fatty acids, secondary bile acids and indole sulfate, etc. These metabolites will affect the physiological process of the host by activating various signal pathways, thus affecting the occurrence and development of cardiovascular diseases (such as coronary heart disease, hypertension, arrhythmia and heart failure).
All the above results suggest that intestinal flora and its metabolites play an important role in promoting the occurrence and development of cardiovascular diseases in depression, but its internal mechanism is not completely clear. Therefore, it is of great significance to deeply explore the pathophysiological mechanism of depression on cardiovascular diseases for guiding the prevention and treatment of cardiovascular diseases.
A total of 300 people were enrolled in this study, which were divided into healthy control group, depression group and depression combined with cardiovascular disease group, with 100 cases in each group. Samples of patients' feces, urine peripheral blood and oral secretions were collected and analyzed by multi-omics. Subsequently, after 6 months, 1 year, 2 years and 5 years after discharge, the clinical prognosis of the patients was obtained and recorded.
The purpose of this study is to discover and deeply explore the pathophysiological mechanism of depression on common cardiovascular diseases (coronary heart disease, hypertension, arrhythmia or heart failure) through the research methods of 16S rDNA sequencing, metagenome sequencing and metabonomics, so as to provide theoretical basis for comprehensive treatment of cardiovascular diseases caused by depression, and at the same time provide potential biomarkers and prevention targets for cardiovascular diseases caused by depression.
- Conditions
- Depression and CVD
- Keywords
- Depression and cardiovascular diseases
- Medical subject headings
- Depression, Cardiovascular Diseases
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 |
|---|---|---|
| Healthy control group | 1) Good health and no gastrointestinal diseases; 2) No previous history of mental illness; 2) No previous history of cardiovascular disease; | |
| Depression group | 1. Meet the diagnostic criteria of the latest guidelines for depression, and be clinically diagnosed by at least two psychiatrists; 2. Patients with first-episode depression; 3. Have not taken any psychoactive drugs before or have not taken any psychoactive drugs within 4 weeks. | |
| Depression with cardiovascular disease group | 1. Meet the diagnostic criteria of the latest guidelines for depression, and be clinically diagnosed by at least two psychiatrists; 2. Patients with first-episode depression; 3. Have not taken any psychoactive drugs before or have not taken any psychoactive drugs within 4 weeks. 4. There is definite clinical evidence of heart failure, coronary heart disease, hypertension or arrhythmia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
data of analysis of multi-omics
Samples of feces, urine and peripheral blood were collected from healthy control group, depression group and depression combined with cardiovascular disease group, and were analyzed by multi-omics. Subsequently, the patients were followed up in the outpatient clinic at 6 months, 1 year, 2 years and 5 years after discharge, and the clinical prognosis details of the patients were obtained and recorded.
Measured: From enrollment to the end of five-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start25 May 2025 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression and CVDStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975592
- Sponsor's protocol ID
- Depression and CVD
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Mechanism of Multi-group Analysis of the Influence of Depression on Common Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT06975592
- Acronym / sponsor ID
- Depression and CVD
- Conditions
- Depression and CVD
- Keywords
- Depression and cardiovascular diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 25 May 2025 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 16 May 2025 (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.
Cardiovascular disease is the main cause of death in the world, accounting for 32% of all deaths. In 2019, the number of people suffering from cardiovascular diseases in the world was about 523 million, of which about 18.6 million died of cardiovascular diseases. Although great progress has been made in reducing the burden of cardiovascular diseases by controlling typical risk factors, there is still a lack of effective intervention means and measures for cardiovascular diseases induced by atypical risk factors (such as environmental pollution, obesity and anxiety and depression).
Depression is a health problem as common as cardiovascular disease, and it has been proved to be an important risk factor of cardiovascular disease. Previous studies have shown that depression is related to the increased risk of subsequent cardiovascular events, including myocardial infarction, angina pectoris, stroke and cardiovascular mortality. The risk of cardiovascular disease in patients with major depression is about 72% higher than that in healthy control group.
Previous studies have shown that compared with healthy people, the intestinal microbial composition of patients with major depression, especially the microbial diversity and the relative abundance of specific bacterial groups, has changed significantly. Many studies have also confirmed that dysbacteriosis may be an important cause of MDD, and with the passage of time, the pathological changes caused by MDD will further destroy the intestinal environment and lead to dysbacteriosis. In addition, intestinal microflora can also produce a variety of important mediators, such as metabolites produced by bacterial fermentation of food, host molecules modified by bacteria (bile acids, etc.) or direct products of bacteria, which also play an important role in the pathogenesis of MDD. In recent years, both population studies and animal experiments have found that the changes in the composition and function of intestinal flora (that is, the imbalance of intestinal microbial flora) will accelerate the occurrence and development of cardiovascular diseases. Intestinal flora will metabolize the food ingested by the host into a series of metabolites, including trimethylamine oxide, short-chain fatty acids, secondary bile acids and indole sulfate, etc. These metabolites will affect the physiological process of the host by activating various signal pathways, thus affecting the occurrence and development of cardiovascular diseases (such as coronary heart disease, hypertension, arrhythmia and heart failure).
All the above results suggest that intestinal flora and its metabolites play an important role in promoting the occurrence and development of cardiovascular diseases in depression, but its internal mechanism is not completely clear. Therefore, it is of great significance to deeply explore the pathophysiological mechanism of depression on cardiovascular diseases for guiding the prevention and treatment of cardiovascular diseases.
A total of 300 people were enrolled in this study, which were divided into healthy control group, depression group and depression combined with cardiovascular disease group, with 100 cases in each group. Samples of patients' feces, urine peripheral blood and oral secretions were collected and analyzed by multi-omics. Subsequently, after 6 months, 1 year, 2 years and 5 years after discharge, the clinical prognosis of the patients was obtained and recorded.
The purpose of this study is to discover and deeply explore the pathophysiological mechanism of depression on common cardiovascular diseases (coronary heart disease, hypertension, arrhythmia or heart failure) through the research methods of 16S rDNA sequencing, metagenome sequencing and metabonomics, so as to provide theoretical basis for comprehensive treatment of cardiovascular diseases caused by depression, and at the same time provide potential biomarkers and prevention targets for cardiovascular diseases caused by depression.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control group | – | –1) Good health and no gastrointestinal diseases; 2) No previous history of mental illness; 2) No previous history of cardiovascular disease; |
| Depression group | – | –1. Meet the diagnostic criteria of the latest guidelines for depression, and be clinically diagnosed by at least two psychiatrists; 2. Patients with first-episode depression; 3. Have not taken any psychoactive drugs before or have not taken any psychoactive drugs within 4 weeks. |
| Depression with cardiovascular disease group | – | –1. Meet the diagnostic criteria of the latest guidelines for depression, and be clinically diagnosed by at least two psychiatrists; 2. Patients with first-episode depression; 3. Have not taken any psychoactive drugs before or have not taken any psychoactive drugs within 4 weeks. 4. There is definite clinical evidence of heart failure, coronary heart disease, hypertension or arrhythmia. |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Samples of feces, urine and peripheral blood were collected from healthy control group, depression group and depression combined with cardiovascular disease group, and were analyzed by multi-omics. Subsequently, the patients were followed up in the outpatient clinic at 6 months, 1 year, 2 years and 5 years after discharge, and the clinical prognosis details of the patients were obtained and recorded.
Key inclusion criteria (8 listed)
- Healthy control group 1) Good health and no gastrointestinal diseases; 2) No previous history of mental illness; 3) No previous history of cardiovascular disease;
- Depression group
- 1) Meet the diagnostic criteria of the latest guidelines for depression, and be clinically diagnosed by at least two psychiatrists; 2) Patients with first-episode depression; 3) Have not taken any psychoactive drugs before or have not taken any psychoactive drugs within 4 weeks.
- 3. Depression with cardiovascular disease group
- Meet the diagnostic criteria of the latest guidelines for depression, and be clinically diagnosed by at least two psychiatrists;
Key exclusion criteria (13 listed)
- Have a history of alcohol dependence, organic brain diseases, nervous system diseases and other complex mental diseases;
- Long-term use of psychoactive drugs/use of psychoactive drugs within 4 weeks;
- Patients with thyroid dysfunction
- Patients with severe liver and kidney dysfunction;
- Patients with chronic obstructive pulmonary disease, interstitial pulmonary fibrosis and pulmonary hypertension;
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
data of analysis of multi-omics
Time frame: From enrollment to the end of five-year follow-up
Samples of feces, urine and peripheral blood were collected from healthy control group, depression group and depression combined with cardiovascular disease group, and were analyzed by multi-omics. Subsequently, the patients were followed up in the outpatient clinic at 6 months, 1 year, 2 years and 5 years after discharge, and the clinical prognosis details of the patients were obtained and recorded.
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: Undecided
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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.
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 Depression and CVD, run by First Affiliated Hospital of Harbin Medical University 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 8 inclusion and 13 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: opening soon, 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 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?
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?
Contact Yue Li Doctor Yue Li, Doctor's degree (+86-13766875068, dcg866@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
data of analysis of multi-omics (time frame: From enrollment to the end of five-year follow-up). 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.