Right Ventricular Haemodynamic Evaluation and Response to Treatment

Right Ventricular Dysfunction Clinical Trial

— Rightheart I  

Official title:

Right Ventricular Haemodynamic Evaluation and Response to Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03403868
• Other study ID #: 108/15
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: December 1, 2021

Study information

• Verified date: November 2020
• Source: University of Giessen
• Contact: Khodr Tello, MD
• Phone: 004964198556087
• Email: khodr.tello[@]innere.med.uni-giessen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

Diagnostic Test:
• conductance catheter
pressure volume loops are assessed via a special catheter (Conductance catheter)

Locations

Country	Name	City	State
Germany	University hospital Giessen	Gießen

Sponsors (2)

Lead Sponsor	Collaborator
University of Giessen	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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