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Status unknownNCT03403868Rightheart IUpdated Dec 1, 2020

Right Ventricular Haemodynamic Evaluation and Response to Treatment

An interventional study of conductance catheter in Right Ventricular Dysfunction, sponsored by University of Giessen. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-01.

Sponsored by University of Giessen · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

Mono-center Study to evaluate different multimodal functional parameter of the right ventricle in PAH-patients

Read the detailed description

Mono-center-study tu evaluate functional parameters in cardiac MRI, conductance catheter (pressure-volume-loops), echocardiography and right heart catheter in PAH patients and to compare different multimodal parameters

02

Conditions studied

  • Right Ventricular Dysfunction
03

In context

Ventricular Dysfunction, Right

90 studies on the registry are indexed under Ventricular Dysfunction, Right; 28 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 38 interventional studies indexed under Ventricular Dysfunction, Right.

Browse Ventricular Dysfunction, Right studies →

Lead sponsor

University of Giessen is the lead sponsor of 95 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • PH Nizza group 1 and patients without pulmonary hypertension after having the right heart catheter on clinical grounds
  • ability to sign
  • male and female between 18 to 85 years

  • haemodynamic criteria:

    • Pulmonary vascular resistance (PVR) > 240 dyn x sec x cm-5
    • Mean Pulmonary artery pressure (mPAP) ≥ 25 mmHg for PAH patients
  • normal haemodynamic in controls
  • therapy-naive or at least since two months stabil therapy with approved drugs for PAH (Sildenafil, Tadalafil, Macitentan, Ambrisentan, Bosentan, Iloprost, Treprostinil, Riociguat).

Exclusion criteria

Exclusion Criteria:

  • therapy with positive inotropic drugs (dobutamin etc.)
  • missing
  • pregnancy or lactation
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    Conductance catheter

    Contractility-measurement with conductance catheter (pressure-volume-catheter)

    Diagnostic Test: conductance catheter

Interventions

  • Diagnostic testconductance catheter

    pressure volume loops are assessed via a special catheter (Conductance catheter)

06

What researchers measure

Primary outcomes

  1. Comparibility of Ees (endsystolic elastance, which describes the right ventricular contractility) derived from conductance catheter, cMRI (cardiac magnetic resonance tomography) and 4D echocardiography

    right ventricular contractility can be obtained via different methods, our aim is to compare the different methods. Ees is the endsystolic elastance which describes the contractility of the right ventricle

    Time frame: 12 weeks

Secondary outcomes

  1. dp/dt max and min from Pressure-Wire vs. Conductance Katheter

    delta pressure/delta time is an indirect parameter of right ventricular contractility, which is load dependent

    Time frame: 12 weeks

  2. Comparibility of volumetry assessed via magnetic resonance tomography (MRI) and 4D echocardiography (ECHO)

    Volumes (end-diastolic and endystolic) are measured via MRI and ECHO and compared with each other

    Time frame: 12 weeks

  3. Comparibility of pressures measured via pressure wire and conductance catheter

    pressurewire measurements (high fidelity catheter) and conductance catheter (pressure volume catheter) are compared with each other

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Kremer N, Rako Z, Douschan P, Gall H, Ghofrani HA, Grimminger F, Guth S, Naeije R, Rieth A, Schulz R, Seeger W, Tedford RJ, Vadasz I, Vanderpool R, Wiedenroth CB, Richter MJ, Tello K. Unmasking right ventricular-arterial uncoupling during fluid challenge in pulmonary hypertension. J Heart Lung Transplant. 2022 Mar;41(3):345-355. doi: 10.1016/j.healun.2021.11.019. Epub 2021 Dec 5. PubMed 34972609 ↗
  • Tello K, Wan J, Dalmer A, Vanderpool R, Ghofrani HA, Naeije R, Roller F, Mohajerani E, Seeger W, Herberg U, Sommer N, Gall H, Richter MJ. Validation of the Tricuspid Annular Plane Systolic Excursion/Systolic Pulmonary Artery Pressure Ratio for the Assessment of Right Ventricular-Arterial Coupling in Severe Pulmonary Hypertension. Circ Cardiovasc Imaging. 2019 Sep;12(9):e009047. doi: 10.1161/CIRCIMAGING.119.009047. Epub 2019 Sep 10. PubMed 31500448 ↗
  • Tello K, Dalmer A, Vanderpool R, Ghofrani HA, Naeije R, Roller F, Seeger W, Wilhelm J, Gall H, Richter MJ. Cardiac Magnetic Resonance Imaging-Based Right Ventricular Strain Analysis for Assessment of Coupling and Diastolic Function in Pulmonary Hypertension. JACC Cardiovasc Imaging. 2019 Nov;12(11 Pt 1):2155-2164. doi: 10.1016/j.jcmg.2018.12.032. Epub 2019 Mar 13. PubMed 30878422 ↗
  • Tello K, Dalmer A, Axmann J, Vanderpool R, Ghofrani HA, Naeije R, Roller F, Seeger W, Sommer N, Wilhelm J, Gall H, Richter MJ. Reserve of Right Ventricular-Arterial Coupling in the Setting of Chronic Overload. Circ Heart Fail. 2019 Jan;12(1):e005512. doi: 10.1161/CIRCHEARTFAILURE.118.005512. PubMed 30616360 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2016, a primary completion of Jun 2021 and a completion of Dec 2021. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 5, 2018
First posted
Jan 19, 2018
Start
Jan 1, 2016
Primary completionEst.
Jun 1, 2021
CompletionEst.
Dec 1, 2021
Last update
Dec 1, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03403868
Lead sponsor
University of Giessen
Collaborators
German Research Foundation
Responsible party
Jan Grimminger (Principle Investigator, University of Giessen) — Principal investigator
First posted
Jan 19, 2018
Start date
Jan 1, 2016
Primary completion
Jun 1, 2021 (estimated)
Completion
Dec 1, 2021 (estimated)
Last update
Dec 1, 2020

Study contacts

Khodr Tello, MD
Contact
khodr.tello@innere.med.uni-giessen.de
004964198556087
Manuel Richter, MD
Contact
manuel.richter@innere.med.uni-giessen.de
004964198556022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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