Valvular Heart DiseaseHestiaNCT07065500
Mechanism and Effect of Novel Metabolites on Valvular Heart Disease
An observational study of Valvular Heart Disease, run by Sun Yat-sen University at 1 site in China.
Trial summary
Valvular heart disease (VHD) is a leading cause of loss of physical function, reduced quality of life and increased longevity.The epidemiology of VHD varies widely across the globe, with functional and degenerative diseases occurring predominantly in high-income countries and rheumatic heart disease occurring… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valvular Heart Disease
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 1 Mar 2030
- How long will I take part?
- 5 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with valvular heart disease during hospitalization were enrolled.
Who may be able to join
- Age ≥18 years, gender is not limited.
- Clinical diagnosis of heart valve disease (including aortic stenosis, aortic valve closure insufficiency due to different etiologies, mitral stenosis, mitral valve closure insufficiency, pulmonic stenosis, pulmonic valve closure insufficiency, tricuspid stenosis and tricuspid closure insufficiency due to different etiologies )
Who cannot join
- Patients unable to provide informed consent
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, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-sen Univerity
Guangzhou, Guangdong, 510000
Xiaodong Zhuang, +8613760755035, zhuangxd3@mail.sysu.edu.cn
About this study
Official title: Mechanism and Effect of Novel Metabolites on Valvular Heart Disease（Hestia Study）
Valvular heart disease (VHD) is a leading cause of loss of physical function, reduced quality of life and increased longevity.The epidemiology of VHD varies widely across the globe, with functional and degenerative diseases occurring predominantly in high-income countries and rheumatic heart disease occurring predominantly in low- and middle-income countries. The prevalence of valvular heart disease (VHD) is increasing globally due to improved survival and aging populations, poorly controlled by medications, with the majority of patients having to undergo surgical or interventional treatments.
It is therefore important to search for novel metabolites and conduct mechanistic studies on the effects of these metabolites on patients with heart valve disease.
In the Hestia study, the investigators looked for risk factors and mechanisms associated with the development and prognosis of VHD through long-term follow-up of VHD patients and metabolite testing of specimen tissues.
- Conditions
- Valvular Heart Disease
- Keywords
- novel metabolites, valvular heart disease, prognosis, Risk Factors
- Medical subject headings
- Heart Valve 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 |
|---|---|---|
| Clinical diagnosis of heart valve disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with All-cause mortality
Measured: 5 years
Secondary outcomes (2)
Number of Participants with cardiovascular events
Measured: 5 years
Number of Participants with progression of valvular heart disease
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Aug 2025
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- 4,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-dong Zhuang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065500
- Sponsor's protocol ID
- Hestia study
- Acronym
- Hestia
- Status last verified
- Mar 2025
- First submitted
- 2 Jul 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism and Effect of Novel Metabolites on Valvular Heart Disease（Hestia Study）
- ClinicalTrials.gov ID
- NCT07065500
- Acronym / sponsor ID
- Hestia / Hestia study
- Conditions
- Valvular Heart Disease
- Keywords
- novel metabolites, valvular heart disease, prognosis, Risk Factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 15 Jul 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.
Valvular heart disease (VHD) is a leading cause of loss of physical function, reduced quality of life and increased longevity.The epidemiology of VHD varies widely across the globe, with functional and degenerative diseases occurring predominantly in high-income countries and rheumatic heart disease occurring predominantly in low- and middle-income countries. The prevalence of valvular heart disease (VHD) is increasing globally due to improved survival and aging populations, poorly controlled by medications, with the majority of patients having to undergo surgical or interventional treatments.
It is therefore important to search for novel metabolites and conduct mechanistic studies on the effects of these metabolites on patients with heart valve disease.
In the Hestia study, the investigators looked for risk factors and mechanisms associated with the development and prognosis of VHD through long-term follow-up of VHD patients and metabolite testing of specimen tissues.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical diagnosis of heart valve disease | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with valvular heart disease during hospitalization were enrolled.
Key inclusion criteria (2 listed)
- Age ≥18 years, gender is not limited.
- Clinical diagnosis of heart valve disease (including aortic stenosis, aortic valve closure insufficiency due to different etiologies, mitral stenosis, mitral valve closure insufficiency, pulmonic stenosis, pulmonic valve closure insufficiency, tricuspid stenosis and tricuspid closure insufficiency due to different etiologies )
Key exclusion criteria (1 listed)
- Patients unable to provide informed consent
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
Number of Participants with All-cause mortality
Time frame: 5 years
2 secondary outcomes
Number of Participants with cardiovascular events
Time frame: 5 years
Number of Participants with progression of valvular heart disease
Time frame: 5 years
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 2 Sep 2025.
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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 Valvular Heart Disease, run by Sun Yat-sen 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 2 Sep 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 Xiaodong Zhuang (+8613760755035, zhuangxd3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with All-cause mortality (time frame: 5 years). 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 2 Sep 2025.