Right Ventricular Haemodynamic Evaluation and Response to Treatment

University of Giessen100 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Right Ventricular Dysfunction

Interventions

conductance catheterDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University hospital Giessen

Giessen, Germany

RECRUITING

Outcomes

Primary Outcomes

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

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

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

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

Central Contacts

Khodr Tello, MD

CONTACT

004964198556087 khodr.tello@innere.med.uni-giessen.de

Manuel Richter, MD

CONTACT

004964198556022 manuel.richter@innere.med.uni-giessen.de

Data from ClinicalTrials.gov

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