- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04505449
Invasive Left Heart Catheterization Registry
October 25, 2022 updated by: Jeong Hoon Yang, Samsung Medical Center
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
404
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 06351
- Samsung Medical Center
-
-
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
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
Retrospectively enrolled symptomatic patients who underwent left heart catheterization
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Left heart catheterization
Symptomatic patients who underwent left heart catheterization and coronary angiography.
|
Patients who underwent left heart catheterization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rates of Death or re-hospitalization due to heart failure
Time Frame: 10 Years
|
10 Years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rates of All-cause death
Time Frame: 10 Years
|
10 Years
|
Rates of Re-hospitalization due to heart failure
Time Frame: 10 Years
|
10 Years
|
Rates of Myocardial infarction
Time Frame: 10 Years
|
10 Years
|
Rates of Stroke
Time Frame: 10 Years
|
10 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
December 13, 2019
Primary Completion (Actual)
December 12, 2020
Study Completion (Actual)
March 31, 2021
Study Registration Dates
First Submitted
August 6, 2020
First Submitted That Met QC Criteria
August 6, 2020
First Posted (Actual)
August 10, 2020
Study Record Updates
Last Update Posted (Actual)
October 27, 2022
Last Update Submitted That Met QC Criteria
October 25, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LHCR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.
Clinical Trials on Heart Failure With Preserved Ejection Fraction
-
University Hospital, AkershusNovartisActive, not recruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionNorway
-
University of SienaEuropean Association of Cardiovascular ImagingActive, not recruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection FractionSpain, Greece, Turkey, Portugal, Australia, Belgium, Italy, Mexico, Netherlands, North Macedonia, Romania, Tunisia
-
Istituti Clinici Scientifici Maugeri SpARecruitingHeart Failure With Preserved Ejection Fraction | Heart Failure With Midrange Ejection FractionItaly
-
Milton S. Hershey Medical CenterWithdrawnHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
-
Board of Trustees of Illinois State UniversityUniversity of Colorado, Denver; Abbott; University of North Carolina, Greensboro and other collaboratorsRecruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
-
Milton S. Hershey Medical CenterCompletedHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
-
Zhijun SunEnrolling by invitationHeart Failure | Heart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection FractionChina
-
Corvia MedicalWithdrawnHeart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection Fraction
-
Occlutech International ABActive, not recruitingHeart Failure With Preserved Ejection Fraction (HFpEF) | Heart Failure With Reduced Ejection Fraction (HFrEF)United States
-
Yale UniversityRecruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure NYHA Class IVUnited States
Clinical Trials on Left heart catheterization
-
University of FloridaCompletedCoronary AngiographyUnited States
-
Aarhus University Hospital SkejbyCompletedAortic Valve StenosisDenmark
-
Rennes University HospitalCompletedDoppler EchocardiographyFrance
-
National Institutes of Health Clinical Center (CC)CompletedSecondary Pulmonary Arterial HypertensionUnited States
-
UOSD Emodinamica Diagnostica e InterventisticaRecruitingPulmonary HypertensionItaly
-
University Hospital, RouenTerminatedAortic Valve Stenosis | Pulmonary HypertensionFrance
-
Mount Sinai Hospital, CanadaHeart and Stroke Foundation of CanadaRecruitingHeart FailureCanada
-
Shanghai 10th People's HospitalRecruitingAtrioventricular Block | Atrial Fibrillation, Persistent | Heart Failure With Reduced Ejection Fraction | Sick Sinus SyndromeChina
-
University Hospital, EssenTerminatedHeart Failure With Preserved Ejection FractionGermany
-
Chinese Pulmonary Vascular Disease Research GroupRecruitingPulmonary Arterial Hypertension | Pulmonary HypertensionChina