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Heart FailureNCT03231774

Comparability of Hemodynamic Parameters Measured by Non-invasive Echocardiography and by Right Heart Catheterization

An observational study of Heart Failure, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
How many people
100 participants
Where
1 siteGermany
Study dates
21 Jul 2017to 31 Jul 2018
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients scheduled for transthoracic echocardiography and right heart catheterization.

Who may be able to join

  • Chronic heart failure NYHA I - IV

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen, North Rhine-Westphalia, 32545

Other trials in Germany

About this study

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

Read the detailed description

Chronic heart failure is a progressive disease in Western population. Echocardiography and right heart catheterization are important tools in the diagnosis and progress monitoring of heart failure.

Gold standard in diagnosis of hemodynamic parameters in patients with heart failure is right heart catheterization. However, this diagnostic device represents an invasive method that is additionally associated with high risks such as infections, vessel and nerve injuries. Echocardiography is probably in a position to determine hemodynamic parameters as reliably as right heart catheterization without additional health risk due to its non-invasive character. All procedures performed are part of clinical Routine. Patients do not undergo any study-specific procedure at all.

Conditions
Heart Failure
Keywords
Echocardiography, Right heart catheterization
Medical subject headings
Heart Failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measurement of systolic, diastolic and mean CVP

    CVP measured in mmHg

    Measured: During a single right heart catheterization procedure

Secondary outcomes (6)

  1. Measurement of systolic, diastolic and mean PAP

    PAP measured in mmHg

    Measured: During a single right heart catheterization procedure

  2. Measurement of systolic, diastolic and mean RVP

    RVP measured in mmHg

    Measured: During a single right heart catheterization procedure

  3. Measurement of systolic, diastolic and mean PAWP

    PAWP measured in mmHg

    Measured: During a single right heart catheterization procedure

  4. Measurement of Cardiac Index CI

    CI measured in l/M/m²

    Measured: During a single right heart catheterization procedure

  5. Measurement of Cardiac Output CO

    CO measured in l/min

    Measured: During a single right heart catheterization procedure

  6. Transthoracic Echocardiography

    Collected data will be analyzed for comparability

    Measured: During a single TTE examination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2017
  2. Study start21 Jul 2017
  3. Primary completion31 Dec 2017
  4. Study completion31 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT03231774
Sponsor's protocol ID
HDZ-KA_011_HF
Status last verified
Sep 2018
First submitted
26 Jun 2017
Last updated
9 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25242802

  • 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.

    PubMed 32445006

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of systolic, diastolic and mean CVP (time frame: During a single right heart catheterization procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03231774, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.

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