Trial document




drksid header

  DRKS00009836

Trial Description

start of 1:1-Block title

Title

Global rEgistry on decongestioN Therapy using Less invasivE UltraFiltration

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

Trial Acronym

GENTLE-UF

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

A multicentre, prospective registry to evaluate the safety and efficacy of minimally invasive ultrafiltration treatment and its effect on symptoms and rehospitalisation in patients with advanced volume overload

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

Brief Summary in Scientific Language

In patients with advanced volume overload, minimally invasive ultrafiltration treatment in the acute phase can have a positive effect on clinical outcome. The aim is to collect treatment data in the context of a prospective registry of the safety and performance of minimally invasive ultrafiltration. The treatment data from each patient will be recorded over 12 months. The knowledge about ultrafiltration in volume overload obtained from the registry, in some cases in combination with a disease management programme, is intended to improve the body of evidence. In addition, the data will be used for hypothesis generation.

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

Organizational Data

  •   DRKS00009836
  •   2015/12/30
  •   2016/03/21
  •   no
  •   Approved
  •   Eth-49/15, Ethik-Kommission der Ärztekammer Berlin
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT02769351  (ClinicalTrials.gov)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I50.14 -  [generalization I50.1: Left ventricular failure]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Assessment of therapy data in a prospective registry on peripheral, minimal invasive ultrafiltration in patients with acute volume overload, preferably in association with cardiac decompensation with signs of incipient diuretic resistance.
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
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Symptom status and rehospitalisation due to exacerbation of heart failure/volume overload of other origin within 12 months

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

Secondary Outcome

other endpoints include safety, feasibility and performance parameters of minimal-invasive ultrafiltration

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

Countries of Recruitment

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

Locations of Recruitment

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

Recruitment

  •   Actual
  •   2015/12/03
  •   500
  •   Multicenter trial
  •   International
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

Age over/equal 18 years, Inpatient-treated patients with acute volume overload, preferably in association with cardiac decompensation with signs of incipient diuretic resistance (lack of increase in urine output despite significant escalation of diuretic therapy; e.g. more than/equal 80 mg furosemide / 24 h or over 1375 mL urine output/40 mg furosemide per 24 h or equivalent dose of other loop diuretics [established clinically or from the medical history]), New York Association Functional Class (NYHA) III-IV at inclusion, Systolic or diastolic cardiac dysfunction (HF-REF or HF-PEF), Adequate venous access (preferably peripheral arm vein) allowing a flow rate more than/equal 60 mL / min, Written consent to the use of data in the registry (where necessary, by a legal guardian).

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

Exclusion Criteria

Contraindication to anticoagulation (e.g. known heparin-induced thrombocytopenia, severe bleeding), Terminal renal failure (stage V, GFR kleiner 15 mL); Cardiogenic shock, e.g. in association with acute coronary syndrome (ACS); Other diseases or factors that, in the study doctor’s opinion, constitute a potential contraindication to ultrafiltration; Pregnant women, women in labour, breast-feeding women or women of childbearing potential, who are without adequate contraception or are planning a family. NB: a pregnancy test is performed systematically in women of childbearing age and the patient is not included in the event of pregnancy (positive test). It is absolutely essential that women, who have a negative test and who are included in the study, have an effective contraception.

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Fresenius Medical Care Deutschland GmbH
    • Ms.  Dr.  Manuela  Stauss-Grabo 
    • Else-Kröner-Straße 1
    • 61352  Bad Homburg
    • 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
    • Fresenius Medical Care Deutschland GmbH
    • Ms.  Dr.  Jennifer  Braun 
    • Else-Kröner-Straße 1
    • 61352  Bad Homburg
    • 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
    • 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
    • Fresenius Medical Care Deutschland GmbH
    • Ms.  Dr.  Jennifer  Braun 
    • Else-Kröner-Straße 1
    • 61352   Bad Homburg
    • 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 suspended on temporary hold
  •   [---]*
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.