Invasive Left Heart Catheterization Registry

Completed

• Conditions: Heart Failure With Preserved Ejection Fraction; Left Ventricular Diastolic Dysfunction
• Interventions: Diagnostic Test: Left heart catheterization

• Registration Number: NCT04505449
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2019-12-13
• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-10
• Primary Completion: 2020-12-12
• Study Completion: 2021-03-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 404

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Left heart catheterization	Left heart catheterization	Symptomatic patients who underwent left heart catheterization and coronary angiography.

Primary Outcome Measures

Name	Time	Method
Rates of Death or re-hospitalization due to heart failure	10 Years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of