NCT05490901

Brief Summary

To evaluate the role of exercise hemodynamic testing in the diagnostic workup for patients with dyspnea on exertion referred to the catheterization lab.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
38mo left

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Mar 2020Jun 2029

Study Start

First participant enrolled

March 17, 2020

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

August 8, 2022

Status Verified

August 1, 2022

Enrollment Period

8.8 years

First QC Date

August 1, 2022

Last Update Submit

August 4, 2022

Conditions

Heart Failure With Preserved Ejection FractionChronic Pulmonary Thromboembolism (Disorder)

Keywords

Exercise hemodynamic testHeart failure with preserved ejection fractionCardiac catheterization

Outcome Measures

Primary Outcomes (1)

  • Proportion of exercise induced pulmonary artery wedge pressure >25 mmHg

    Number of Participants with Diagnosis of earlier heart failure with preserved ejection fraction based on exercise PCWP

    during the procedure

Secondary Outcomes (14)

  • Proportion of exercise induced pulmonary hypertension > 30 mmHg

    during the procedure

  • Correlation between peripheral venous pressure and right atrial pressure assumed by echocardiography

    during the procedure

  • Ventilatory mechanics

    during the procedure

  • Aerobic capacity

    during the procedure

  • coronary flow reserve

    during the procedure

  • +9 more secondary outcomes

Study Arms (1)

Patients with Unexplained Dyspnea

Patients with dyspnea on exertion

Diagnostic Test: Exercise hemodynamic test

Interventions

Exercise hemodynamic testDIAGNOSTIC_TEST

Assessment of pulmonary hemodynamics during exercise by right heart catheterization and cardiac function during exercise by a simultaneous transthoracic echocardiography

Also known as: Exercise cath
Patients with Unexplained Dyspnea

Eligibility Criteria

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

All patients with dyspnea on exertion who undergo right heart catheterization and echocardiography during exercise due to clinical reasons.

You may qualify if:

  • Subject must be at least 19 years of age.
  • Patients with dyspnea on exertion
  • Written informed consent of participating subjects after being fully briefed (for prospective analysis)

You may not qualify if:

  • Patients with incomplete hemodynamic data at rest or exercise
  • Advanced tumor disease or other diseases with a short life expectancy
  • Uncontrolled systemic arterial hypertension ( \> 160/100 mmHg at rest)
  • FEV1\<50% predicted
  • TLC\<60% predicted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Study Officials

  • Jeong Hoon Yang, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeong Hoon Yang, MD

CONTACT

82-2-3410-3419jhysmc@gmail.com

Ki Hong Choi, MD

CONTACT

82-2-3410-6653cardiokh@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 8, 2022

Study Start

March 17, 2020

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

June 30, 2029

Last Updated

August 8, 2022

Record last verified: 2022-08

Locations

KR(1)