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

Primary Purpose

Right Ventricular Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
conductance catheter
Sponsored by
University of Giessen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Right Ventricular Dysfunction

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University hospital GiessenRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Conductance catheter

Arm Description

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

Outcomes

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
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
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)
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
pressurewire measurements (high fidelity catheter) and conductance catheter (pressure volume catheter) are compared with each other

Full Information

First Posted
January 5, 2018
Last Updated
November 30, 2020
Sponsor
University of Giessen
Collaborators
German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03403868
Brief Title
Right Ventricular Haemodynamic Evaluation and Response to Treatment
Acronym
Rightheart I
Official Title
Right Ventricular Haemodynamic Evaluation and Response to Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (undefined)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Giessen
Collaborators
German Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Ventricular Dysfunction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conductance catheter
Arm Type
Other
Arm Description
Contractility-measurement with conductance catheter (pressure-volume-catheter)
Intervention Type
Diagnostic Test
Intervention Name(s)
conductance catheter
Intervention Description
pressure volume loops are assessed via a special catheter (Conductance catheter)
Primary Outcome Measure Information:
Title
Comparibility of Ees (endsystolic elastance, which describes the right ventricular contractility) derived from conductance catheter, cMRI (cardiac magnetic resonance tomography) and 4D echocardiography
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
dp/dt max and min from Pressure-Wire vs. Conductance Katheter
Description
delta pressure/delta time is an indirect parameter of right ventricular contractility, which is load dependent
Time Frame
12 weeks
Title
Comparibility of volumetry assessed via magnetic resonance tomography (MRI) and 4D echocardiography (ECHO)
Description
Volumes (end-diastolic and endystolic) are measured via MRI and ECHO and compared with each other
Time Frame
12 weeks
Title
Comparibility of pressures measured via pressure wire and conductance catheter
Description
pressurewire measurements (high fidelity catheter) and conductance catheter (pressure volume catheter) are compared with each other
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khodr Tello, MD
Phone
004964198556087
Email
khodr.tello@innere.med.uni-giessen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Richter, MD
Phone
004964198556022
Email
manuel.richter@innere.med.uni-giessen.de
Facility Information:
Facility Name
University hospital Giessen
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khodr Tello, MD
Phone
004964198556087
Email
khodr.tello@innere.med.uni-giessen.de
First Name & Middle Initial & Last Name & Degree
Manuel Richter, MD
Phone
004964198556022
Email
manuel.richter@innere.med.uni-giessen.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34972609
Citation
Kremer N, Rako Z, Douschan P, Gall H, Ghofrani HA, Grimminger F, Guth S, Naeije R, Rieth A, Schulz R, Seeger W, Tedford RJ, Vadasz I, Vanderpool R, Wiedenroth CB, Richter MJ, Tello K. Unmasking right ventricular-arterial uncoupling during fluid challenge in pulmonary hypertension. J Heart Lung Transplant. 2022 Mar;41(3):345-355. doi: 10.1016/j.healun.2021.11.019. Epub 2021 Dec 5.
Results Reference
derived
PubMed Identifier
31500448
Citation
Tello K, Wan J, Dalmer A, Vanderpool R, Ghofrani HA, Naeije R, Roller F, Mohajerani E, Seeger W, Herberg U, Sommer N, Gall H, Richter MJ. Validation of the Tricuspid Annular Plane Systolic Excursion/Systolic Pulmonary Artery Pressure Ratio for the Assessment of Right Ventricular-Arterial Coupling in Severe Pulmonary Hypertension. Circ Cardiovasc Imaging. 2019 Sep;12(9):e009047. doi: 10.1161/CIRCIMAGING.119.009047. Epub 2019 Sep 10.
Results Reference
derived
PubMed Identifier
30878422
Citation
Tello K, Dalmer A, Vanderpool R, Ghofrani HA, Naeije R, Roller F, Seeger W, Wilhelm J, Gall H, Richter MJ. Cardiac Magnetic Resonance Imaging-Based Right Ventricular Strain Analysis for Assessment of Coupling and Diastolic Function in Pulmonary Hypertension. JACC Cardiovasc Imaging. 2019 Nov;12(11 Pt 1):2155-2164. doi: 10.1016/j.jcmg.2018.12.032. Epub 2019 Mar 13.
Results Reference
derived
PubMed Identifier
30616360
Citation
Tello K, Dalmer A, Axmann J, Vanderpool R, Ghofrani HA, Naeije R, Roller F, Seeger W, Sommer N, Wilhelm J, Gall H, Richter MJ. Reserve of Right Ventricular-Arterial Coupling in the Setting of Chronic Overload. Circ Heart Fail. 2019 Jan;12(1):e005512. doi: 10.1161/CIRCHEARTFAILURE.118.005512.
Results Reference
derived

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Right Ventricular Haemodynamic Evaluation and Response to Treatment

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