Invasive Left Heart Catheterization Registry

Heart Failure With Preserved Ejection Fraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04505449
• Other study ID #: LHCR
• Status: Completed
• Start date: December 13, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: October 2022
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: March 31, 2021
• Est. primary completion date: December 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Left Ventricular Diastolic Dysfunction

Intervention

Diagnostic Test:
• Left heart catheterization
Patients who underwent left heart catheterization

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of Death or re-hospitalization due to heart failure		10 Years
Secondary	Rates of All-cause death		10 Years
Secondary	Rates of Re-hospitalization due to heart failure		10 Years
Secondary	Rates of Myocardial infarction		10 Years
Secondary	Rates of Stroke		10 Years