Trial document




drksid header

  DRKS00006245

Trial Description

start of 1:1-Block title

Title

Pulmonary Hypertension Registry Mainz

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

PHYREM

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Patients with pulmonary hypertension will be cared for clinical means over a period of 3 years and the examination results will be added to a registry. The goal of the study is to discover a possibly occuring impairment or worsening of the function of the heart and lungs as early as possible by follow-up visits for treatment purposes. In addition, indicators (so-called biomarkers) will be indentified in blood samples which provide information about the current condition of the lungs and heart as well as the exspected clinical course.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The goal of the prospective epidemiological observational study is to evaluate the diagnostic, prognostic, and therapeutic strategies as well as the clinical long-term course of patients with confirmed diagnosis of pulmonary hypertension (PH).

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006245
  •   2015/04/30
  •   [---]*
  •   yes
  •   Approved
  •   837.406.14 (9645), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I27.2 -  Other secondary pulmonary hypertension
  •   I27.0 -  Primary pulmonary hypertension
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients with confirmed diagnosis of pulmonary hypertension will be followed every 6 months over a period of 3 years by documentation of clinical, imaging, and laboratory examination results.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

This prospective non-interventional study aims to evaluate the diagnostic, prognostic, and therapeutic strategies as well as the clinical long-term course of patients with confirmed diagnosis of pulmonary hypertension.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

(1) To determine the prognostic value of the following parameters at diagnosis in relation to the patients’ clinical long-term outcome: (a) clinical (symptoms, clinical signs, predisposing (history) criteria and comorbidities), (b) imaging (echocardiography, if indicated: V/Q lung scan, computed tomographic (CT) angiography, magnetic resonance tomographic (MRT) angiography, conventional selective pulmonary angiography), and (c) laboratory (biomarker tests); (2) to find out optimal „cut-off“-values of different biomarkers from the categories mentioned above and to develop novel algorithms for risk stratification; (3) to analyze the course of these parameters or biomarkers as indicators of the response to therapy; (4) to identify novel diagnostic and prognostic biomarkers (under development and resulting from translational CTH research) in different patient groups of PH; (5) to investigate the influence of established and new therapeutic substances/schemes, and/or surgical/interventional therapies, on the prognosis, the functional status, and life quality of patients and to gather the progresses related to PH management on the long-term outcome.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/12/14
  •   300
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

(1) Confirmed diagnosis of pulmonary Hypertension and (2) written informed consent of study participants or their legal representative.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Anticipated non-compliance or inability to adhere to study protocol (deficient willingness or ability to cooperate).

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Mr.  Prof. Dr.  Stavros  Konstantinides 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Mr.  Prof.  Stavros  Konstantinides 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Actelion Pharmaceuticals Deutschland GmbH
    • Konrad-Goldmann-Str. 5b
    • 79100  Freiburg i.B.
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.