The Prognostic Role and Diagnostic Efficacy of Exercise Right Heart Catheterization With a Simultaneous Echocardiography in Patients With Dyspnea on Exertion (EX_CATH)

August 4, 2022 updated by: Jeong Hoon Yang, Samsung Medical Center

A Retrospective and Prospective Cohort Study to Investigate the Prognostic Role and Diagnostic Efficacy of Exercise Right Heart Catheterization With a Simultaneous Echocardiography in Patients With Dyspnea on Exertion

To evaluate the role of exercise hemodynamic testing in the diagnostic workup for patients with dyspnea on exertion referred to the catheterization lab.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that has no proven effective treatment. However, in practice, it's difficult to recognize early stage of HFpEF by resting hemodynamic study and echocardiography because the patients mainly complaint of dyspnea only during exercise but not resting condition. Accordingly, exercise stress test will be helpful to provide more information on pathophysiology, diagnosis, and severity in various cardiovascular diseases such as HFpEF, valvular heart disease, and chronic thromboembolic pulmonary hypertension. Thus, the broad objective of this proposal is to characterize the dynamic changes in cardiopulmonary mechanics during stress in patients with exertional dyspnea, establishing a comprehensive multimodality diagnostic approach to the evaluation of exercise intolerance. Specifically, this study will compare established and novel parameters derived from echocardiography and CPX with simultaneous, gold standard invasive measures of cardiovascular hemodynamics at rest and with exercise stress to define the role of noninvasive testing in the diagnostic workup for patients with dyspnea on exertion referred to the catheterization lab.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Jeong Hoon Yang, MD
  • Phone Number: 82-2-3410-3419
  • Email: jhysmc@gmail.com

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with dyspnea on exertion who undergo right heart catheterization and echocardiography during exercise due to clinical reasons.

Description

Inclusion Criteria:

  • Subject must be at least 19 years of age.
  • Patients with dyspnea on exertion
  • Written informed consent of participating subjects after being fully briefed (for prospective analysis)

Exclusion Criteria:

  • Patients with incomplete hemodynamic data at rest or exercise
  • Advanced tumor disease or other diseases with a short life expectancy
  • Uncontrolled systemic arterial hypertension ( > 160/100 mmHg at rest)
  • FEV1<50% predicted
  • TLC<60% predicted

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with Unexplained Dyspnea
Patients with dyspnea on exertion
Diagnostic test: Exercise hemodynamic test
Assessment of pulmonary hemodynamics during exercise by right heart catheterization and cardiac function during exercise by a simultaneous transthoracic echocardiography
Other Names:
  • Exercise cath

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of exercise induced pulmonary artery wedge pressure >25 mmHg
Time Frame: during the procedure
Number of Participants with Diagnosis of earlier heart failure with preserved ejection fraction based on exercise PCWP
during the procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of exercise induced pulmonary hypertension > 30 mmHg
Time Frame: during the procedure
Number of Participants with Diagnosis of pulmonary hypertension based on mean pulmonary pressure at peak exercise
during the procedure
Correlation between peripheral venous pressure and right atrial pressure assumed by echocardiography
Time Frame: during the procedure
Correlation between peripheral venous pressure and right atrial pressure assumed by echocardiography
during the procedure
Ventilatory mechanics
Time Frame: during the procedure
ratio of minute ventilation to carbon dioxide production (VE/VCO2)
during the procedure
Aerobic capacity
Time Frame: during the procedure
peak oxygen consumption (VO2)
during the procedure
coronary flow reserve
Time Frame: during the procedure
invasively measured coronary flow reserve
during the procedure
index of microcirculatory resistance
Time Frame: during the procedure
invasively measured index of microcirculatory resistance
during the procedure
Lactate level at peak exercise
Time Frame: during the procedure
Serum lactate level at peak exercise
during the procedure
LA stiffness
Time Frame: during the procedure
LA stiffness measured by LA strain/E/e' using Transthoracic echocardiography
during the procedure
change of E/e' between at rest and peak exercise
Time Frame: between at rest and peak exercise
The change of E/e' between at rest and peak exercise
between at rest and peak exercise
Rates of rehospitalization due to heart failure
Time Frame: 5 years follow-up
Rehospitalization due to heart failure
5 years follow-up
Rates of all-cause death
Time Frame: 5 years follow-up
Follow-up death
5 years follow-up
The change of right ventricular systolic pressure (RVSP) between at rest and peak exercise
Time Frame: between at rest and peak exercise
The change of RVSP between at rest and peak exercise
between at rest and peak exercise
change of Tricuspid annular plane systolic excursion (TAPSE) between at rest and peak exercise
Time Frame: between at rest and peak exercise
The change of TAPSE between at rest and peak exercise
between at rest and peak exercise
change of S' between at rest and peak exercise
Time Frame: between at rest and peak exercise
The change of S' between at rest and peak exercise
between at rest and peak exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samsung Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeong Hoon Yang, MD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EX_CATH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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