18 and older, any sex, with Acute Heart Failure or Cardiac Decompensation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Rehospitalisation (Yes/no) Due to Exacerbation of Heart Failure/Volume Overload of Other OriginPrimary· 12 months
The number of rehospitalizations due to heart failure resp. volume overload has been measured as a clinical endpoint and analyzed based on the AP.
Rehospitalization due to Heart Failure
Group
Value
95% CI
Periph. Minimal Invasive Ultrafiltration
7
Rehospitalization due to other reasons
Group
Value
95% CI
Periph. Minimal Invasive Ultrafiltration
12
Significant Deterioration of Kidney Function - CreatinineSecondary· Recruitment; Discharge from Index Hospitalization; Outpatient visit I (3-9 months); Outpatient visit II ( 12 months)
Significant deterioration of kidney function has been measured as a safety endpoint and analyzed based on the SP. The variables have been measured at recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months) and Outpatient visit II (12 months).
Creatinine at Recruitment
Group
Value
95% CI
Periph. Minimal Invasive Ultrafiltration
208.30
± 71.79
Creatinine at Discharge from Index Hospitalization
Group
Value
95% CI
Periph. Minimal Invasive Ultrafiltration
180.66
± 78.13
Creatinine at Outpatient visit I
Group
Value
95% CI
Periph. Minimal Invasive Ultrafiltration
224.99
± 162.7
Creatinine at Outpatient visit II
Group
Value
95% CI
Periph. Minimal Invasive Ultrafiltration
430.31
± 454.01
Significant Deterioration of Kidney Function - UreaSecondary· Recruitment; Discharge from Index Hospitalization; Outpatient visit I (3-6 months); Outpatient visit II (12 months)
Significant deterioration of kidney function has been measured as a safety endpoint and analyzed based on the SP. The variables have been measured at recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months) and Outpatient visit II (12 months).
Urea at Recruitment
Group
Value
95% CI
Periph. Minimal Invasive Ultrafiltration
21.7
± 15.01
Urea at Discharge from Index Hospitalization
Group
Value
95% CI
Periph. Minimal Invasive Ultrafiltration
51.67
± 168.40
Urea at Outpatient visit I
Group
Value
95% CI
Periph. Minimal Invasive Ultrafiltration
282.99
± 457.51
Significant Deterioration of Kidney Function - eGFR (Estimated Glomerular Filtration Rate)Secondary· Recruitment, Discharge from index hospitalization, Outapteint visit I (3-6 months), Outpatient visit II (12 months)
Significant deterioration of kidney function has been measured as a safety endpoint and analyzed based on the SP. The variables have been measured at recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months) and Outpatient visit II (12 months).
eGFR at Recruitment
Group
Value
95% CI
Periph. Minimal Invasive Ultrafiltration
28.58
± 15.56
eGFR at Discharge from Index hositalization
Group
Value
95% CI
Periph. Minimal Invasive Ultrafiltration
37.82
± 24.48
eGFR at Outaptient visit I
Group
Value
95% CI
Periph. Minimal Invasive Ultrafiltration
36.19
± 30.87
eGFR at Outpatient visit II
Group
Value
95% CI
Periph. Minimal Invasive Ultrafiltration
41.52
± 52.96
Significant Deterioration of Kidney Function - CystatinSecondary· recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months), Outpatient visit II (12 months)
Significant deterioration of kidney function has been measured as a safety endpoint and analyzed based on the SP. The variables have been measured at recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months) and Outpatient visit II (12 months).
Cystatin at Recruitment
Group
Value
95% CI
Periph. Minimal Invasive Ultrafiltration
2.26
± 1.72
Cystatin at Discharge from index Hospitalization
Group
Value
95% CI
Periph. Minimal Invasive Ultrafiltration
0.09
± 0.13
Cystatin at Outpatient visit II
Group
Value
95% CI
Periph. Minimal Invasive Ultrafiltration
6.99
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from signing the informed consent up to 12 month after recruitment..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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 data will be recorded via an electronic case report form (eCRF); the eCRF runs on a server located in Germany and complies with current data protection regulations. It is intended to include about 300-500 patients with advanced volume overload at a minimum of 10 sites. In addition, data on a disease management programme (in-body measurement and home monitoring) will be recorded in up to 40 of these patients. The treatment data from each patient will be recorded over 12 months. An interim analysis will be performed after 150 patients have been observed for 6 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by Fresenius Medical Care Deutschland GmbH
Last refreshed: 5 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02769351.