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Clinical Trials/NCT04505449
NCT04505449
Completed
Not Applicable

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

Samsung Medical Center1 site in 1 country404 target enrollmentDecember 13, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure With Preserved Ejection Fraction
Sponsor
Samsung Medical Center
Enrollment
404
Locations
1
Primary Endpoint
Rates of Death or re-hospitalization due to heart failure
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
December 13, 2019
End Date
March 31, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeong Hoon Yang

Professor

Samsung Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Rates of Death or re-hospitalization due to heart failure

Time Frame: 10 Years

Secondary Outcomes

  • Rates of All-cause death(10 Years)
  • Rates of Stroke(10 Years)
  • Rates of Re-hospitalization due to heart failure(10 Years)
  • Rates of Myocardial infarction(10 Years)

Study Sites (1)

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