CVP-guided Aquapheresis for the Treatment of Acute Congestion in Heart Failure
Aquadex
1 other identifier
observational
9
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedFirst Posted
Study publicly available on registry
March 5, 2014
CompletedMarch 17, 2015
March 1, 2015
4 months
February 28, 2014
March 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in central venous pressure
Changes from Baseline to 48 h after intervention
Secondary Outcomes (8)
amount of net fluid loss
48 h
Measure of dyspnea using a visual analog scale
Changes from Baseline to 48 h after intervention
heart function
7 days
Biomarker
Changes from Baseline to 48 h after intervention
Time until impaired plasma refill rate
48 h
- +3 more secondary outcomes
Interventions
Eligibility Criteria
Patients with chronic heart failure listed for LVAD
You may qualify if:
- Patients with chronic heart failure scheduled for LVAD
- Indication for CVVH/Aquapheresis
You may not qualify if:
- Renal Disease (GFR \<20 ml / min)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf
Düsseldorf, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ralf Westenfeld, MD
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf
- STUDY CHAIR
Malte Kelm, MD
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Klinik für Kardiologie, Pneumologie und Angiologie
Study Record Dates
First Submitted
February 28, 2014
First Posted
March 5, 2014
Study Start
November 1, 2013
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
March 17, 2015
Record last verified: 2015-03