Heart Failure With Preserved Ejection FractionNCT04505449
Invasive Left Heart Catheterization Registry
An observational study of Heart Failure With Preserved Ejection Fraction and Left Ventricular Diastolic Dysfunction, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Retrospectively enrolled suspicious of heart failure with preserved ejection fraction (HFpEF) patients who underwent left heart catheterization with the measurement of left ventricular end-diastolic pressure. 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, Left Ventricular Diastolic Dysfunction
- What is being tested?
- Left heart catheterization
- How many people
- 404 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Dec 2019to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Retrospectively enrolled symptomatic patients who underwent left heart catheterization
Who may be able to join
- Left ventricular ejection fraction > 50%
- Patients who had a symptom and/or signs of heart failure (dyspnea on exertion, chest discomfort, fatigue, dizziness, or ankle edema)
- Patients who underwent left heart catheterization with the measurement of left ventricular end-diastolic pressure
Who cannot join
- Left ventricular ejection fraction <50%
- Acute coronary syndrome
- More than moderate valvular heart disease
- Primary cardiomyopathies such as dilated cardiomyopathy and hypertrophic cardiomyopathy, amyloidosis
- Pulmonary arterial hypertension
- Heart transplantation
- Constrictive pericarditis
- Stress-induced cardiomyopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Invasive Left Heart Catheterization for Patients Suspected Heart Failure With Preserved Ejection Fraction
Retrospectively enrolled suspicious of heart failure with preserved ejection fraction (HFpEF) patients who underwent left heart catheterization with the measurement of left ventricular end-diastolic pressure.
Read the detailed description
Heart failure (HF) with preserved ejection fraction (HFpEF) remains a poorly understood clinical syndrome without effective targeted therapies. The clinical syndrome of HFpEF develops from a complex interaction of several risk factors such as aging, obesity, hypertension, myocardial ischemia, and arterial stiffness that cause organ dysfunction and, ultimately, clinical symptoms. Although the H2FPEF and HFA-PEFF scores have recently been proposed to estimate the probability of HFpEF in patients suffering from unexplained dyspnea, diagnosing HFpEF remains still challenging. The aim of the current registry was to evaluate the role of invasive left heart catheterization with the measurement of left ventricular end-diastolic pressure (LVEDP) in suspicious of HFpEF patients.
- Being tested
- Left heart catheterization
- Keywords
- Heart failure with preserved ejection fraction, Left ventricular end diastolic pressure, Echocardiography
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left heart catheterizationDiagnostic test
Patients who underwent left heart catheterization
| Study group | Role | What they receive |
|---|---|---|
| Left heart catheterization | Symptomatic patients who underwent left heart catheterization and coronary angiography. Receives: Diagnostic Test: Left heart catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Death or re-hospitalization due to heart failure
Measured: 10 Years
Secondary outcomes (4)
Rates of All-cause death
Measured: 10 Years
Rates of Re-hospitalization due to heart failure
Measured: 10 Years
Rates of Myocardial infarction
Measured: 10 Years
Rates of Stroke
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start13 Dec 2019
- Primary completion12 Dec 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Retrospective
- Enrolment
- 404 participants (actual)
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
- NCT04505449
- Sponsor's protocol ID
- LHCR
- Status last verified
- Oct 2022
- First submitted
- 6 Aug 2020
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi KH, Yang JH, Seo JH, Hong D, Youn T, Joh HS, Lee SH, Kim D, Park TK, Lee JM, Song YB, Choi JO, Hahn JY, Choi SH, Gwon HC, Jeon ES. Discriminative Role of Invasive Left Heart Catheterization in Patients Suspected of Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2023 Mar 21;12(6):e027581. doi: 10.1161/JAHA.122.027581. Epub 2023 Mar 9.
PubMed 36892042
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Invasive Left Heart Catheterization for Patients Suspected Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT04505449
- Acronym / sponsor ID
- LHCR
- Keywords
- Heart failure with preserved ejection fraction, Left ventricular end diastolic pressure, Echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 10 Aug 2020 (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.
Retrospectively enrolled suspicious of heart failure with preserved ejection fraction (HFpEF) patients who underwent left heart catheterization with the measurement of left ventricular end-diastolic pressure.
Detailed description
Heart failure (HF) with preserved ejection fraction (HFpEF) remains a poorly understood clinical syndrome without effective targeted therapies. The clinical syndrome of HFpEF develops from a complex interaction of several risk factors such as aging, obesity, hypertension, myocardial ischemia, and arterial stiffness that cause organ dysfunction and, ultimately, clinical symptoms. Although the H2FPEF and HFA-PEFF scores have recently been proposed to estimate the probability of HFpEF in patients suffering from unexplained dyspnea, diagnosing HFpEF remains still challenging. The aim of the current registry was to evaluate the role of invasive left heart catheterization with the measurement of left ventricular end-diastolic pressure (LVEDP) in suspicious of HFpEF patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Left heart catheterization | – | Diagnostic Test: Left heart catheterizationSymptomatic patients who underwent left heart catheterization and coronary angiography. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospectively enrolled symptomatic patients who underwent left heart catheterization
Key inclusion criteria (3 listed)
- Left ventricular ejection fraction > 50%
- Patients who had a symptom and/or signs of heart failure (dyspnea on exertion, chest discomfort, fatigue, dizziness, or ankle edema)
- Patients who underwent left heart catheterization with the measurement of left ventricular end-diastolic pressure
Key exclusion criteria (8 listed)
- Left ventricular ejection fraction <50%
- Acute coronary syndrome
- More than moderate valvular heart disease
- Primary cardiomyopathies such as dilated cardiomyopathy and hypertrophic cardiomyopathy, amyloidosis
- Pulmonary arterial hypertension
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 |
|---|---|---|
| Left heart catheterizationPatients who underwent left heart catheterization | Diagnostic test | Left heart catheterization |
Primary outcome
Rates of Death or re-hospitalization due to heart failure
Time frame: 10 Years
4 secondary outcomes
Rates of All-cause death
Time frame: 10 Years
Rates of Re-hospitalization due to heart failure
Time frame: 10 Years
Rates of Myocardial infarction
Time frame: 10 Years
Rates of Stroke
Time frame: 10 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Derived from this study: PubMed 36892042Choi KH, Yang JH, Seo JH, Hong D, Youn T, Joh HS, Lee SH, Kim D, Park TK, Lee JM, Song YB, Choi JO, Hahn JY, Choi SH, Gwon HC, Jeon ES. Discriminative Role of Invasive Left Heart Catheterization in Patients Suspected of Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2023 Mar 21;12(6):e027581. doi: 10.1161/JAHA.122.027581. Epub 2023 Mar 9.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Left Ventricular Diastolic Dysfunction, 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 8 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: finished, as of the sponsor's last update on 27 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of Death or re-hospitalization due to heart failure (time frame: 10 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04505449, which also lists 1 linked publication.
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 27 Oct 2022; AzTrials last refreshed its copy on 27 Oct 2026.