Invasive Left Heart Catheterization Registry

NCT ID: NCT04505449

Last Updated: 2022-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

404 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-13

Study Completion Date

2021-03-31

Brief Summary

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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

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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.

Conditions

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Heart Failure With Preserved Ejection Fraction Left Ventricular Diastolic Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Left heart catheterization

Symptomatic patients who underwent left heart catheterization and coronary angiography.

Left heart catheterization

Intervention Type DIAGNOSTIC_TEST

Patients who underwent left heart catheterization

Interventions

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Left heart catheterization

Patients who underwent left heart catheterization

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeong Hoon Yang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Hoon Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 36892042 (View on PubMed)

Other Identifiers

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LHCR

Identifier Type: -

Identifier Source: org_study_id

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