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Clinical Trials/NCT03403868
NCT03403868
Unknown
N/A

Right Ventricular Haemodynamic Evaluation and Response to Treatment

University of Giessen1 site in 1 country100 target enrollmentJanuary 1, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Right Ventricular Dysfunction
Sponsor
University of Giessen
Enrollment
100
Locations
1
Primary Endpoint
Comparibility of Ees (endsystolic elastance, which describes the right ventricular contractility) derived from conductance catheter, cMRI (cardiac magnetic resonance tomography) and 4D echocardiography
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 1, 2016
End Date
December 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jan Grimminger

Principle Investigator

University of Giessen

Eligibility Criteria

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

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

Time Frame: 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 Outcomes

  • dp/dt max and min from Pressure-Wire vs. Conductance Katheter(12 weeks)
  • Comparibility of volumetry assessed via magnetic resonance tomography (MRI) and 4D echocardiography (ECHO)(12 weeks)
  • Comparibility of pressures measured via pressure wire and conductance catheter(12 weeks)

Study Sites (1)

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