NCT04505449

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
404

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

August 6, 2020

Last Update Submit

October 25, 2022

Conditions

Heart Failure With Preserved Ejection FractionLeft Ventricular Diastolic Dysfunction

Keywords

Heart failure with preserved ejection fractionLeft ventricular end diastolic pressureEchocardiography

Outcome Measures

Primary Outcomes (1)

  • Rates of Death or re-hospitalization due to heart failure

    10 Years

Secondary Outcomes (4)

  • Rates of All-cause death

    10 Years

  • Rates of Re-hospitalization due to heart failure

    10 Years

  • Rates of Myocardial infarction

    10 Years

  • Rates of Stroke

    10 Years

Study Arms (1)

Left heart catheterization

Symptomatic patients who underwent left heart catheterization and coronary angiography.

Diagnostic Test: Left heart catheterization

Interventions

Left heart catheterizationDIAGNOSTIC_TEST

Patients who underwent left heart catheterization

Left heart catheterization

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrospectively enrolled symptomatic patients who underwent left heart catheterization

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (1)

  • Choi KH, Yang JH, Seo JH, Hong D, Youn T, Joh HS, Lee SH, Kim D, Park TK, Lee JM, Song YB, Choi JO, Hahn JY, Choi SH, Gwon HC, Jeon ES. Discriminative Role of Invasive Left Heart Catheterization in Patients Suspected of Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2023 Mar 21;12(6):e027581. doi: 10.1161/JAHA.122.027581. Epub 2023 Mar 9.

    PMID: 36892042DERIVED

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Study Officials

  • Jeong Hoon Yang, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 10, 2020

Study Start

December 13, 2019

Primary Completion

December 12, 2020

Study Completion

March 31, 2021

Last Updated

October 27, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)