Global rEgistry on decongestioN Therapy using Less invasivE UltraFiltration

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00009836
• Date of registration: 30/12/2015
• Prospective Registration: No
• Primary sponsor: Fresenius Medical Care Deutschland GmbH
• Public title: Global rEgistry on decongestioN Therapy using Less invasivE UltraFiltration
• Scientific title: Global rEgistry on decongestioN Therapy using Less invasivE UltraFiltration - GENTLE-UF
• Date of first enrolment: 03/12/2015
• Target sample size: 500
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00009836
• Study type: observational
• Study design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: treatment

Countries of recruitment

Germany, Sweden, Switzerland

Contacts

• Name: Henning T. Baberg
• Affiliation: Helios Klinikum Berlin BuchKlinik und Poliklinik für Kardiologie und Nephrologie

• Name: Jennifer Braun
• Affiliation: Fresenius Medical Care Deutschland GmbH

Key inclusion & exclusion criteria

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).

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.


Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

I50.14

I50.14

Intervention(s)

Group 1: 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.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

NCT02769351

Source(s) of Monetary Support

Fresenius Medical Care Deutschland GmbH

Ethics review

Status: Approved
Approval date: 06/10/2015
Contact:

[e-mail]

Ethik-Kommission der Ärztekammer Berlin

([phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 10/02/2023
• Date Completed: 04/03/2019
• URL: http://drks.de/search/en/trial/DRKS00009836#studyResults