Feasibility Assessment of the Aquadex FlexFlowTM Ultrafiltration System in Treating Non Hospitalized Heart Failure Patients in Dedicated Heart Failure Centers

Completed

• Conditions: Heart Failure
• Interventions: Procedure: blood ultrafiltration

• Registration Number: NCT01654926
• Lead Sponsor: Clalit Health Services

Brief Summary

Ultrafiltration (UF) technology is unique for its ability to extract fluid as an isotonic solution, therefore not causing substantial changes in NaCl concentrations, and the use of peripheral veins makes it feasible to use in out of hospital medical centers, for non compensated Heart Failure (HF) with a low response to diuretics. The use of UF in the United States and Europe in out of hospital HF centers is accepted as daily practice. Therefore the hypothesis of this study is that it is feasible for a professional team to effectively use the UF for short courses on non compensated HF patients with low or no response to Diuretics, in a dedicated out of hospital HF center.

Detailed Description

The patients will be treated in the LIN Heart Failure Center and will not include population defined in the Exclusion criteria.

Up to 60 patients will be recruited and each one will undergo up to 30 treatments in time intervals defined by the cardiologist according to the clinical needs throughout the duration of the study.

Inclusion duration of every patient will be terminated at the end of the treatment course. No prevention in adding more treatment courses per patient according to clinical needs upon the cardiologist's decision.

Operating the UF system:

During the treatment course two of the patient's peripheral veins will be cannulated. One will be used to draw blood from, and the other will be used to return the blood back in to the patient.

The patient will be administered with Heparin IV, or Clexane SC with an ACT target of 180-200 that will be monitored every 4-6 hours.

Fluid removal rate will be according to the cardiologists discretion and will not exceed 500 ml/hour Patient monitoring - Pulse and BP will be recorded at baseline, after 10 minutes for treatment onset and every 1 hour.

Study Timeline

• Study First Submitted: 2012-07-29
• Study First Submitted QC: 2012-07-31
• Study First Posted: 2012-08-01
• Study Start: 2012-12
• Primary Completion: 2013-09
• Study Completion: 2013-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-08
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

HF patients with peripheral or pulmonic fluid retention, with little or no response to Diuretics as defined by the referring cardiologist

Exclusion Criteria

1. Age < 18 years

2. Patient does not fully comprehend the Essence of the study and can not sign the informed consent.

3. Patient is participating in a drug or any other treatment study (no prevention to include patients participating in studies of non invasive monitoring technologies.

4. Presence of Acute MI

5. CR base values > 3mg/dl

6. Hemodynamic instability requiring Inotropic agents

7. HT base values > 45%

8. Known pregnancy

9. Presence of contraindication to anticoagulants

10. Post heart transplant or cardiac assist device implantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart Failure patients	blood ultrafiltration	-

Primary Outcome Measures

Name	Time	Method
Feasibility Assessment of the Aquadex FlexFlowTM Ultrafiltration System in Treating Non-Hospitalized Heart Failure Patients in Dedicated Heart Failure Centers	12 months	The propose of the study is to observe the administrative needs of performing the treatment at our specific out-patient clinic. Of note the treatment is already approved including the indication and the place we are doing it so we merely aim to look at administrative and logistic that need to be done.

Trial Locations

Locations (1)

Lin Clinic; 🇮🇱 Haifa, Israel