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OpenTrials
Completed

NCT Number: NCT02079259

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf

Düsseldorf, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Renal Disease (GFR <20 ml / min)

Treatment and study plan

Ultrafiltration

Procedure

Primary outcomes

  1. Changes in central venous pressure

    Time frame: Changes from Baseline to 48 h after intervention

Secondary outcomes

  1. amount of net fluid loss

    Time frame: 48 h

  2. Measure of dyspnea using a visual analog scale

    Time frame: Changes from Baseline to 48 h after intervention

  3. heart function

    Time frame: 7 days

    right/left heart function measured by Echocardiography and BNP (Brain Natriuretic Peptide)

  4. Biomarker

    Time frame: Changes from Baseline to 48 h after intervention

    GFR, Cystatin C, HCO3-, NT-proBNP, CK, Troponin, Hematocrit

  5. Time until impaired plasma refill rate

    Time frame: 48 h

  6. blood pressure

    Time frame: Changes from Baseline to 48 h after intervention

  7. heart rate

    Time frame: Changes from Baseline to 48 h after intervention

  8. Serum Creatinine level

    Time frame: 48 h

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

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

Acronym: Aquadex

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 5, 2014
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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