Right Ventricular Haemodynamic Evaluation and Response to Treatment

Not Applicable

• Conditions: Right Ventricular Dysfunction
• Interventions: Diagnostic Test: conductance catheter

• Registration Number: NCT03403868
• Lead Sponsor: University of Giessen

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

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2018-01-05
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-19
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-30
• Last Update Posted: 2020-12-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Conductance catheter	conductance catheter	Contractility-measurement with conductance catheter (pressure-volume-catheter)

Primary Outcome Measures

Name	Time	Method
Comparibility of Ees (endsystolic elastance, which describes the right ventricular contractility) derived from conductance catheter, cMRI (cardiac magnetic resonance tomography) and 4D echocardiography	12 weeks	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

Secondary Outcome Measures

Name	Time	Method
dp/dt max and min from Pressure-Wire vs. Conductance Katheter	12 weeks	delta pressure/delta time is an indirect parameter of right ventricular contractility, which is load dependent
Comparibility of volumetry assessed via magnetic resonance tomography (MRI) and 4D echocardiography (ECHO)	12 weeks	Volumes (end-diastolic and endystolic) are measured via MRI and ECHO and compared with each other
Comparibility of pressures measured via pressure wire and conductance catheter	12 weeks	pressurewire measurements (high fidelity catheter) and conductance catheter (pressure volume catheter) are compared with each other

Trial Locations

Locations (1)

University hospital Giessen; 🇩🇪 Gießen, Germany