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

NCT ID: NCT02079259

Last Updated: 2015-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Ultrafiltration

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Klinik für Kardiologie, Pneumologie und Angiologie

Klinik für Kardiologie, Pneumologie und Angiologie

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ralf Westenfeld, MD

Role: PRINCIPAL_INVESTIGATOR

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

Malte Kelm, MD

Role: STUDY_CHAIR

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

Locations

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

Düsseldorf, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Aquadex

Identifier Type: -

Identifier Source: org_study_id

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