NCT07367893

Brief Summary

Exercise echocardiography is a widely used non-invasive test that evaluates cardiac structure and function during physical stress. It provides important information on myocardial ischemia, cardiac performance, hemodynamic responses, and exercise capacity in patients with a broad range of heart diseases. However, real-world prospective data integrating exercise echocardiographic findings across both ischemic and non-ischemic heart disease remain limited. This prospective observational registry aims to systematically collect clinical, exercise, and echocardiographic data from patients undergoing clinically indicated exercise echocardiography. The registry includes patients with suspected or established ischemic heart disease as well as those with non-ischemic cardiac conditions, such as cardiomyopathies, heart failure, valvular heart disease, and exercise-related symptoms. The collected data will be used to evaluate exercise-induced changes in cardiac structure and function, identify phenotypes associated with adverse clinical outcomes, and improve risk stratification in routine clinical practice. The registry is observational in nature and does not alter standard clinical care.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
116mo left

Started Apr 2026

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 Progress2%
Apr 2026Dec 2035

First Submitted

Initial submission to the registry

December 30, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

4.8 years

First QC Date

December 30, 2025

Last Update Submit

May 20, 2026

Conditions

Keywords

Exercise echocardiographyIschemic heart diseasenon-ischemic heart diseaseclinical outcome

Outcome Measures

Primary Outcomes (1)

  • Change in left ventricular ejection fraction (LVEF) measured by transthoracic echocardiography (TTE)

    Left ventricular ejection fraction (LVEF) will be assessed by transthoracic echocardiography (TTE) using the biplane method of disks (modified Simpson's method), and the change from baseline to 1 year will be analyzed.

    Baseline and 1 year

Secondary Outcomes (2)

  • Composite of cardiovascular death and hospitalization for worsening heart failure (HF) assessed by clinical event adjudication

    Up to 1 year

  • Change in exercise capacity (metabolic equivalents, METs) measured by symptom-limited exercise test

    Baseline and 1 year

Study Arms (1)

Eligible participants include adult patients referred for exercise echocardiography

Eligible participants include adult patients referred for exercise echocardiography for evaluation of: * Suspected or known ischemic heart disease * Non-ischemic heart disease, including cardiomyopathy, heart failure, valvular heart disease, or structural heart disease * Exercise-related symptoms such as dyspnea, chest discomfort, or reduced exercise tolerance

Eligibility Criteria

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

The study population includes adult patients who undergo clinically indicated exercise echocardiography as part of routine cardiovascular care. Participants are referred for evaluation of suspected or established ischemic heart disease as well as a broad range of non-ischemic heart diseases, including cardiomyopathy, heart failure, valvular heart disease, and structural heart disease. Patients are required to be able to perform exercise-based stress testing using standard treadmill or bicycle protocols and to have interpretable echocardiographic images obtained at rest and during exercise. This registry reflects a real-world clinical population in which exercise echocardiography is used for diagnostic and prognostic assessment across diverse cardiovascular conditions.

You may qualify if:

  • Adults aged 18 years or older
  • Patients referred for clinically indicated exercise echocardiography as part of routine clinical care
  • Patients evaluated for suspected or known ischemic heart disease, or non-ischemic heart disease, including but not limited to: Cardiomyopathy, Heart failure, Valvular heart disease, Structural heart disease
  • Ability to perform exercise-based stress testing using treadmill or bicycle protocols
  • Availability of baseline clinical data and interpretable echocardiographic images obtained during rest and exercise
  • Provision of informed consent, or eligibility for consent waiver in accordance with institutional review board approval

You may not qualify if:

  • Inability to perform exercise testing due to non-cardiac limitations, such as severe orthopedic, neurologic, or pulmonary conditions
  • Poor echocardiographic image quality that does not allow meaningful interpretation of exercise-induced changes
  • Any condition deemed by the treating physician to make participation inappropriate or unsafe, even within an observational framework

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Yongin Severance Hospital

Yongin, Gyeonggi-do, 16995, South Korea

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

SungA Bae, MD., PhD.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 30, 2025

First Posted

January 26, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2035

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations