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Completed

NCT Number: NCT04505449

Invasive Left Heart Catheterization Registry

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Left heart catheterization

Diagnostic Test

Patients who underwent left heart catheterization

Primary outcomes

  1. Rates of Death or re-hospitalization due to heart failure

    Time frame: 10 Years

Secondary outcomes

  1. Rates of All-cause death

    Time frame: 10 Years

  2. Rates of Re-hospitalization due to heart failure

    Time frame: 10 Years

  3. Rates of Myocardial infarction

    Time frame: 10 Years

  4. Rates of Stroke

    Time frame: 10 Years

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Role of Invasive Left Heart Catheterization for Patients Suspected Heart Failure With Preserved Ejection Fraction

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Aug 10, 2020
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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