Trial document




drksid header

  DRKS00010804

Trial Description

start of 1:1-Block title

Title

Genetic background of arterial hypertension

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

Trial Acronym

[---]*

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

URL of the Trial

http:///

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

Brief Summary in Lay Language

Goal of our investigation is it to find by gene analyses (DNA from a blood test) genetic variants (mutations) in patients with therapy resistant hypertension. It is known for a long time that hypertension is more prevalent in certain families. This is a reference that this illness has probably at least partial hereditary components, which we want to identify. So far only a small number at mutations in individual genes could be made responsible as an exclusive cause of hypertension in comparatively few families. This is above all because of the fact that hypertension can be a complex, polygenetic illness, which is further influenced by environmental factors. Furthermore genetic causes of hypertension have so far not sufficiently been explored. The proof of such changes in the genetic make-up is however of great importance in order to understand the impact of certain environmental factors and to develop purposeful treatments. This will permit conclusions regarding the illness processes in the respective patient.

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

Brief Summary in Scientific Language

To date approx. 25 monogenetic causes for arterial hypertension from the overlapping clinical spectra of cardiogenic, nephrogenic and endocrine phenotypes are known. With the help of new sequencing methods a relevant number of new monogenetic forms of hypertension have been identified in recent years. Considering the small number of known genetic forms of hypertension and the high frequency and clinical variability of arterial hypertension it is to be assumed that a very large genetic heterogeneity and a relevant number of yet unidentified monogenetic and complex-genetic forms of hypertension exist.
Goals of the present research project are:
i) the examination of specific risk variants for essential arterial hypertension in our well characterized patient cohort.
ii) the identification of new risk variants in candidate genes.
iii) the identification of so far unknown genetic causes of hypertension.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00010804
  •   2016/07/11
  •   [---]*
  •   yes
  •   Approved
  •   16-101, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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

  •   I10.0 -  [generalization I10: Essential (primary) hypertension]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients with therapy resistant hypertension
    Intervention: genotyping of DNA from blood sample.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Epidemiological 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

Prevalence of known genetic variants of hypertension.

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

Secondary Outcome

Genotypes of risk variants
Genepanel analysis
Exome (WES)- or genomesequencing (WGS)

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

  •   Planned
  •   2016/08/01
  •   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
  •   99   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients with therapy resistant hypertension.

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

Exclusion Criteria

Age < 18 yrs. Secondary causes of hypertension, pseudohypertension.

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitäres Hypertoniezentrum Köln
    • Mr.  Prof. Dr.  Hannes  Reuter 
    • Kerpener Str. 62
    • 50937  Köln
    • 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 other
    • Institut für HumangenetikUniversität zu Köln
    • Mr.  Dr.  Bodo  Beck 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Universitäres Hypertoniezentrum Köln
    • Mr.  Prof. Dr.  Hannes  Reuter 
    • Kerpener Str. 62
    • 50937  Köln
    • 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
    • Universitäres Hypertoniezentrum Köln
    • Mr.  Prof. Dr.  Hannes  Reuter 
    • Kerpener Str. 62
    • 50937  Köln
    • 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
    • Universitäres Hypertoniezentrum Köln
    • Mr.  Prof. Dr.  Hannes  Reuter 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
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.