Right Ventricular Haemodynamic Evaluation and Response to Treatment
NCT ID: NCT03403868
Last Updated: 2020-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2016-01-01
2021-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Conductance catheter
Contractility-measurement with conductance catheter (pressure-volume-catheter)
conductance catheter
pressure volume loops are assessed via a special catheter (Conductance catheter)
Interventions
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conductance catheter
pressure volume loops are assessed via a special catheter (Conductance catheter)
Eligibility Criteria
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Inclusion Criteria
* ability to sign informed consent
* 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
* missing informed consent
* pregnancy or lactation
18 Years
85 Years
ALL
Yes
Sponsors
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German Research Foundation
OTHER
University of Giessen
OTHER
Responsible Party
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Jan Grimminger
Principle Investigator
Locations
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University hospital Giessen
Giessen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Khodr Tello, MD
Role: primary
Manuel Richter, MD
Role: backup
References
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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.
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.
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.
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.
Other Identifiers
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108/15
Identifier Type: -
Identifier Source: org_study_id