Right Ventricular Haemodynamic Evaluation and Response to Treatment (Rightheart I)

November 30, 2020 updated by: Jan Grimminger, University of Giessen
Mono-center Study to evaluate different multimodal functional parameter of the right ventricle in PAH-patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Gießen, Germany, 35392
        • Recruiting
        • University Hospital Gießen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Giessen

Collaborators

German Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 5, 2018

First Submitted That Met QC Criteria

January 17, 2018

First Posted (Actual)

January 19, 2018

Study Record Updates

Last Update Posted (Actual)

December 1, 2020

Last Update Submitted That Met QC Criteria

November 30, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 108/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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