Heart Failure With Preserved Ejection FractionEX_CATHNCT05490901
The Prognostic Role and Diagnostic Efficacy of Exercise Right Heart Catheterization With a Simultaneous Echocardiography in Patients With Dyspnea on Exertion
An observational study of Heart Failure With Preserved Ejection Fraction and Chronic Pulmonary Thromboembolism (Disorder), run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To evaluate the role of exercise hemodynamic testing in the diagnostic workup for patients with dyspnea on exertion referred to the catheterization lab. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Chronic Pulmonary Thromboembolism (Disorder)
- What is being tested?
- Exercise hemodynamic test
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Mar 2020to 30 Jun 2029
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with dyspnea on exertion who undergo right heart catheterization and echocardiography during exercise due to clinical reasons.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Jeong Hoon Yang, MD, 82-2-3410-3419, jhysmc@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure With Preserved Ejection Fraction, Chronic Pulmonary Thromboembolism (Disorder)
- Being tested
- Exercise hemodynamic test
- Keywords
- Exercise hemodynamic test, Heart failure with preserved ejection fraction, Cardiac catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise hemodynamic testDiagnostic test
Also called Exercise cath
Assessment of pulmonary hemodynamics during exercise by right heart catheterization and cardiac function during exercise by a simultaneous transthoracic echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Patients with Unexplained Dyspnea | Patients with dyspnea on exertion Receives: Diagnostic Test: Exercise hemodynamic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of exercise induced pulmonary artery wedge pressure >25 mmHg
Number of Participants with Diagnosis of earlier heart failure with preserved ejection fraction based on exercise PCWP
Measured: during the procedure
Secondary outcomes (14)
Proportion of exercise induced pulmonary hypertension > 30 mmHg
Number of Participants with Diagnosis of pulmonary hypertension based on mean pulmonary pressure at peak exercise
Measured: during the procedure
Correlation between peripheral venous pressure and right atrial pressure assumed by echocardiography
Correlation between peripheral venous pressure and right atrial pressure assumed by echocardiography
Measured: during the procedure
Ventilatory mechanics
ratio of minute ventilation to carbon dioxide production (VE/VCO2)
Measured: during the procedure
Aerobic capacity
peak oxygen consumption (VO2)
Measured: during the procedure
coronary flow reserve
invasively measured coronary flow reserve
Measured: during the procedure
index of microcirculatory resistance
invasively measured index of microcirculatory resistance
Measured: during the procedure
Lactate level at peak exercise
Serum lactate level at peak exercise
Measured: during the procedure
LA stiffness
LA stiffness measured by LA strain/E/e' using Transthoracic echocardiography
Measured: during the procedure
change of E/e' between at rest and peak exercise
The change of E/e' between at rest and peak exercise
Measured: between at rest and peak exercise
Rates of rehospitalization due to heart failure
Rehospitalization due to heart failure
Measured: 5 years follow-up
Rates of all-cause death
Follow-up death
Measured: 5 years follow-up
The change of right ventricular systolic pressure (RVSP) between at rest and peak exercise
The change of RVSP between at rest and peak exercise
Measured: between at rest and peak exercise
change of Tricuspid annular plane systolic excursion (TAPSE) between at rest and peak exercise
The change of TAPSE between at rest and peak exercise
Measured: between at rest and peak exercise
change of S' between at rest and peak exercise
The change of S' between at rest and peak exercise
Measured: between at rest and peak exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start17 Mar 2020
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- 400 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Hoon Yang, Samsung Medical Center
- Investigators
- Jeong Hoon Yang, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490901
- Sponsor's protocol ID
- EX_CATH
- Acronym
- EX_CATH
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05490901
- Acronym / sponsor ID
- EX_CATH / EX_CATH
- Conditions
- Heart Failure With Preserved Ejection Fraction, Chronic Pulmonary Thromboembolism (Disorder)
- Keywords
- Exercise hemodynamic test, Heart failure with preserved ejection fraction, Cardiac catheterization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 8 Aug 2022 (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.
To evaluate the role of exercise hemodynamic testing in the diagnostic workup for patients with dyspnea on exertion referred to the catheterization lab.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Unexplained Dyspnea | – | Diagnostic Test: Exercise hemodynamic testPatients with dyspnea on exertion |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with dyspnea on exertion who undergo right heart catheterization and echocardiography during exercise due to clinical reasons.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise hemodynamic testAlso: Exercise cathAssessment of pulmonary hemodynamics during exercise by right heart catheterization and cardiac function during exercise by a simultaneous transthoracic echocardiography | Diagnostic test | Patients with Unexplained Dyspnea |
Primary outcome
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
14 secondary outcomes
Proportion of exercise induced pulmonary hypertension > 30 mmHg
Time frame: during the procedure
Correlation between peripheral venous pressure and right atrial pressure assumed by echocardiography
Time frame: during the procedure
Ventilatory mechanics
Time frame: during the procedure
Aerobic capacity
Time frame: during the procedure
coronary flow reserve
Time frame: during the procedure
index of microcirculatory resistance
Time frame: during the procedure
Lactate level at peak exercise
Time frame: during the procedure
LA stiffness
Time frame: during the procedure
change of E/e' between at rest and peak exercise
Time frame: between at rest and peak exercise
Rates of rehospitalization due to heart failure
Time frame: 5 years follow-up
Rates of all-cause death
Time frame: 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
change of Tricuspid annular plane systolic excursion (TAPSE) between at rest and peak exercise
Time frame: between at rest and peak exercise
change of S' between at rest and peak exercise
Time frame: between at rest and peak exercise
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 8 Aug 2022.
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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.
Jeong Hoon Yang, MD principal investigator
Samsung Medical Center
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 Heart Failure With Preserved Ejection Fraction and Chronic Pulmonary Thromboembolism (Disorder), run by Samsung Medical Center at 1 site in South Korea.
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 3 inclusion and 5 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 8 Aug 2022. 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 South Korea. 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 Jeong Hoon Yang, MD (82-2-3410-3419, jhysmc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of exercise induced pulmonary artery wedge pressure >25 mmHg (time frame: during the procedure). 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 8 Aug 2022.