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CVP-guided Aquapheresis for the Treatment of Acute Congestion in Heart Failure

CVP-guided Aquapheresis for the Treatment of Acute Congestion in Heart Failure - A Pilot Study to Optimize Individualized Volume Depletion

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02079259
Acronym
Aquadex
Enrollment
9
Registered
2014-03-05
Start date
2013-11-30
Completion date
2014-03-31
Last updated
2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

The number of patients with acute congestion on chronic heart failure is increasing. Ultrafiltration has recently been proposed as an alternative approach for the stabilization of volume balance, especially in patients with imminent diuretic resistance. There is increasing evidence that ultrafiltration may relief cardiac congestion with lesser effects on blood pressure and activation of renin angiotensin system, respectively . However, recent studies revealed conflicting results: demonstration the superiority of ultrafiltration in comparison to diuretic treatment, and a lack of evidence of benefit, as well as an excess of adverse events with ultrafiltration. Aquapheresis with adapted ultrafiltration rate guided by central venous pressure is safer than aquaphesis with a constant ultrafiltration with comparable effectiveness

Interventions

Sponsors

Heinrich-Heine University, Duesseldorf
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with chronic heart failure scheduled for LVAD * Indication for CVVH/Aquapheresis

Exclusion criteria

* Renal Disease (GFR \<20 ml / min)

Design outcomes

Primary

MeasureTime frame
Changes in central venous pressureChanges from Baseline to 48 h after intervention

Secondary

MeasureTime frameDescription
Measure of dyspnea using a visual analog scaleChanges from Baseline to 48 h after intervention
heart function7 daysright/left heart function measured by Echocardiography and BNP (Brain Natriuretic Peptide)
BiomarkerChanges from Baseline to 48 h after interventionGFR, Cystatin C, HCO3-, NT-proBNP, CK, Troponin, Hematocrit
amount of net fluid loss48 h
blood pressureChanges from Baseline to 48 h after intervention
heart rateChanges from Baseline to 48 h after intervention
Serum Creatinine level48 h
Time until impaired plasma refill rate48 h

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026