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

Completed

• Conditions: Heart Failure

• Registration Number: NCT02079259
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-02-28
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-13
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

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

Exclusion Criteria

• Renal Disease (GFR <20 ml / min)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in central venous pressure	Changes from Baseline to 48 h after intervention

Secondary Outcome Measures

Name	Time	Method
Serum Creatinine level	48 h
amount of net fluid loss	48 h
heart rate	Changes from Baseline to 48 h after intervention
heart function	7 days	right/left heart function measured by Echocardiography and BNP (Brain Natriuretic Peptide)
Biomarker	Changes from Baseline to 48 h after intervention	GFR, Cystatin C, HCO3-, NT-proBNP, CK, Troponin, Hematocrit
Time until impaired plasma refill rate	48 h
Measure of dyspnea using a visual analog scale	Changes from Baseline to 48 h after intervention
blood pressure	Changes from Baseline to 48 h after intervention

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf; 🇩🇪 Duesseldorf, Germany