Test-Retest Reliability of Cardiopulmonary Exercise Testi... | NCT07281534

Studies
Test-Retest Reliability of Cardiopulmonary Exercise Testing With Echocardiography

NCT07281534

Sponsor

Ziekenhuis Oost-Limburg

Status

Recruiting

Last Update Posted

Dec 15, 2025Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Dyspnea; Cardiac

Interventions

CPETecho

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2025Actual

Primary Completion Date

Mar 1, 2026Estimated

Completion Date

Jun 1, 2026Estimated

First Submitted Date

Feb 26, 2024

First Submission Date that Met QC Criteria

Dec 12, 2025

First Posted Date

Dec 15, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2025

Last Update Posted Date

Dec 15, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

CPETecho is progressively employed in diagnostic settings for pathophysiological detection, offering comprehensive assessment of both pulmonary and cardiac functions. This technique evolves from its invasive counterpart, where a diagnostic catheter is employed for hemodynamic monitoring, by substituting the invasive component with non-invasive echocardiography. Nevertheless, data on the test-retest reliability of CPETecho remain sparse, a factor critical in differentiating between measurement effects and actual therapeutic impacts.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single arm	Other	Repeat CPET echo with a one-week interval	Diagnostic Test: CPETecho

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CPETecho	Diagnostic Test	repeat CPETecho with a one-week interval	Single arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation coefficient (ICC)	Analysing the Test-Retest Reliability of Cardiopulmonary Exercise Testing with Echocardiography	Up to 2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Capable of performing a maximal exercise test.
Provide signed and dated informed consent.

Exclusion Criteria:

- Unstable symptoms, whereby therapy cannot be delayed for a week.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Philippe Bertrand, MD, PhD	Contact	0032471626094		philippe.bertrand@zol.be
Sebastiaan Dhont, MD	Contact	0032471626094		sebastiaan.dhont@zol.be

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ziekenhuis Oost-Limburg	Recruiting	Genk		3600	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004417	Dyspnea

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided