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

Conditions

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

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.
Diagnostic test: Left heart catheterization
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

Samsung Medical Center

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.

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