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Right Ventricular Haemodynamic Evaluation and Response to Treatment

Right Ventricular Haemodynamic Evaluation and Response to Treatment

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03403868
Acronym
Rightheart I
Enrollment
100
Registered
2018-01-19
Start date
2016-01-01
Completion date
2021-12-01
Last updated
2020-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Right Ventricular Dysfunction

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

Interventions

DIAGNOSTIC_TESTconductance catheter

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

Sponsors

German Research Foundation
CollaboratorOTHER
University of Giessen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Comparibility of Ees (endsystolic elastance, which describes the right ventricular contractility) derived from conductance catheter, cMRI (cardiac magnetic resonance tomography) and 4D echocardiography12 weeksright 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

MeasureTime frameDescription
dp/dt max and min from Pressure-Wire vs. Conductance Katheter12 weeksdelta 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 weeksVolumes (end-diastolic and endystolic) are measured via MRI and ECHO and compared with each other
Comparibility of pressures measured via pressure wire and conductance catheter12 weekspressurewire measurements (high fidelity catheter) and conductance catheter (pressure volume catheter) are compared with each other

Countries

Germany

Contacts

Primary ContactKhodr Tello, MD
khodr.tello@innere.med.uni-giessen.de004964198556087
Backup ContactManuel Richter, MD
manuel.richter@innere.med.uni-giessen.de004964198556022

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026