NCT03403868

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

5.4 years

First QC Date

January 5, 2018

Last Update Submit

November 30, 2020

Conditions

Right Ventricular Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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

    12 weeks

Secondary Outcomes (3)

  • 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 Arms (1)

Conductance catheter

OTHER

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

Diagnostic Test: conductance catheter

Interventions

conductance catheterDIAGNOSTIC_TEST

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

Conductance catheter

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • therapy with positive inotropic drugs (dobutamin etc.)
  • missing informed consent
  • pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Giessen

Giessen, 35392, Germany

RECRUITING

Related Publications (4)

  • 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.

    PMID: 34972609DERIVED

  • 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.

    PMID: 31500448DERIVED

  • 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.

    PMID: 30878422DERIVED

  • 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.

    PMID: 30616360DERIVED

MeSH Terms

Conditions

Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Central Study Contacts

Khodr Tello, MD

CONTACT

004964198556087khodr.tello@innere.med.uni-giessen.de

Manuel Richter, MD

CONTACT

004964198556022manuel.richter@innere.med.uni-giessen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 5, 2018

First Posted

January 19, 2018

Study Start

January 1, 2016

Primary Completion

June 1, 2021

Study Completion

December 1, 2021

Last Updated

December 1, 2020

Record last verified: 2020-11

Locations

DE(1)