NCT07065500

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
47mo left

Started Aug 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Aug 2025Mar 2030

First Submitted

Initial submission to the registry

July 2, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

September 2, 2025

Status Verified

March 1, 2025

Enrollment Period

4.6 years

First QC Date

July 2, 2025

Last Update Submit

August 29, 2025

Conditions

Keywords

novel metabolitesvalvular heart diseaseprognosisRisk Factors

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with All-cause mortality

    5 years

Secondary Outcomes (2)

  • Number of Participants with cardiovascular events

    5 years

  • Number of Participants with progression of valvular heart disease

    5 years

Study Arms (1)

Clinical diagnosis of heart valve disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients diagnosed with valvular heart disease during hospitalization were enrolled.

You may qualify if:

  • 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 )

You may not qualify if:

  • Patients unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen Univerity

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

July 2, 2025

First Posted

July 15, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Last Updated

September 2, 2025

Record last verified: 2025-03

Locations