Clinical trial NCT03403868: Right Ventricular Haemodynamic Evaluation and Response to Treatment
Official title: Right Ventricular Haemodynamic Evaluation and Response to Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Right Ventricular Dysfunction
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2018-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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

Eligibility criteria: Inclusion Criteria:

* PH Nizza group 1 and patients without pulmonary hypertension after having the right heart catheter on clinical grounds
* 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:

* therapy with positive inotropic drugs (dobutamin etc.)
* missing informed consent
* pregnancy or lactation

Primary outcomes:
measure: Comparibility of Ees (endsystolic elastance, which describes the right ventricular contractility) derived from conductance catheter, cMRI (cardiac magnetic resonance tomography) and 4D echocardiography
timeFrame: 12 weeks
Secondary outcomes:
measure: dp/dt max and min from Pressure-Wire vs. Conductance Katheter
timeFrame: 12 weeks
measure: Comparibility of volumetry assessed via magnetic resonance tomography (MRI) and 4D echocardiography (ECHO)
timeFrame: 12 weeks
measure: Comparibility of pressures measured via pressure wire and conductance catheter
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: University hospital Giessen
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.