NCT03231774

Brief Summary

This study is to compare transthoracic Echocardiography TTE to the gold standard Right Heart Catheterization in Terms of accuracy to measure hemodynamic parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

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

First Submitted

Initial submission to the registry

June 26, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

July 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

October 9, 2020

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

June 26, 2017

Last Update Submit

October 7, 2020

Conditions

Heart Failure

Keywords

EchocardiographyRight heart catheterization

Outcome Measures

Primary Outcomes (1)

  • Measurement of systolic, diastolic and mean CVP

    CVP measured in mmHg

    During a single right heart catheterization procedure

Secondary Outcomes (6)

  • Measurement of systolic, diastolic and mean PAP

    During a single right heart catheterization procedure

  • Measurement of systolic, diastolic and mean RVP

    During a single right heart catheterization procedure

  • Measurement of systolic, diastolic and mean PAWP

    During a single right heart catheterization procedure

  • Measurement of Cardiac Index CI

    During a single right heart catheterization procedure

  • Measurement of Cardiac Output CO

    During a single right heart catheterization procedure

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients scheduled for transthoracic echocardiography and right heart catheterization.

You may qualify if:

  • Chronic heart failure NYHA I - IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Related Publications (2)

  • Fox H, Puehler T, Schulz U, Bitter T, Horstkotte D, Oldenburg O. Delayed recovery from Cheyne-Stokes respiration in heart failure after successful cardiac transplantation: a case report. Transplant Proc. 2014 Sep;46(7):2462-3. doi: 10.1016/j.transproceed.2014.06.063.

    PMID: 25242802RESULT

  • Szymczyk T, Sauzet O, Paluszkiewicz LJ, Costard-Jackle A, Potratz M, Rudolph V, Gummert JF, Fox H. Non-invasive assessment of central venous pressure in heart failure: a systematic prospective comparison of echocardiography and Swan-Ganz catheter. Int J Cardiovasc Imaging. 2020 Oct;36(10):1821-1829. doi: 10.1007/s10554-020-01889-3. Epub 2020 May 22.

    PMID: 32445006RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2017

First Posted

July 27, 2017

Study Start

July 21, 2017

Primary Completion

December 31, 2017

Study Completion

July 31, 2018

Last Updated

October 9, 2020

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)