Rightheart I: Right Ventricular Haemodynamic Evaluation and Response to Treatment

Sponsor

University of Giessen (Other)

Overall Status

Recruiting

CT.gov ID

NCT03403868

Collaborator

German Research Foundation (Other)

100

Enrollment

Location

Arm

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Right Ventricular Dysfunction	Diagnostic Test: conductance catheter	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Right Ventricular Haemodynamic Evaluation and Response to Treatment

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Conductance catheter Contractility-measurement with conductance catheter (pressure-volume-catheter)	Diagnostic Test: conductance catheter pressure volume loops are assessed via a special catheter (Conductance catheter)

Arm

Intervention/Treatment

Other: Conductance catheter

Contractility-measurement with conductance catheter (pressure-volume-catheter)

Diagnostic Test: conductance catheter

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University hospital Giessen	Gießen		Germany	35392

Sponsors and Collaborators

University of Giessen
German Research Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jan Grimminger, Principle Investigator, University of Giessen

ClinicalTrials.gov Identifier:

NCT03403868

Other Study ID Numbers:

108/15

First Posted:

Jan 19, 2018

Last Update Posted:

Dec 1, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ventricular Dysfunction

Ventricular Dysfunction, Right

Study Results

No Results Posted as of Dec 1, 2020