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

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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Procedure: Ultrafiltration

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• Germany
  • Duesseldorf, Germany
    • Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic heart failure listed for LVAD

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Renal Disease (GFR <20 ml / min)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in central venous pressure	Changes from Baseline to 48 h after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	right/left heart function measured by Echocardiography and BNP (Brain Natriuretic Peptide)	7 days
Biomarker	GFR, Cystatin C, HCO3-, NT-proBNP, CK, Troponin, Hematocrit	Changes from Baseline to 48 h after intervention
Time until impaired plasma refill rate		48 h
blood pressure		Changes from Baseline to 48 h after intervention
heart rate		Changes from Baseline to 48 h after intervention
Serum Creatinine level		48 h

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Study Chair: Malte Kelm, MD, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: February 28, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (ESTIMATE): March 5, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 13, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Aquadex