Right Ventricular Haemodynamic Evaluation and Response to Treatment

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

Detailed Description
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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

Official Title
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Right Ventricular Haemodynamic Evaluation and Response to Treatment

Conditions
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Right Ventricular Dysfunction

Intervention / Treatment
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* Diagnostic Test: conductance catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Conductance catheter<br>Contractility-measurement with conductance catheter (pressure-volume-catheter) | Diagnostic Test: conductance catheter<br>* pressure volume loops are assessed via a special catheter (Conductance catheter)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 
| 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 | 12 weeks | 
| 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 | 12 weeks |