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

This study is not yet open for participant recruitment.
Verified July 2012 by Clalit Health Services
Sponsor:
Information provided by (Responsible Party):
Dr. Ofer Amir, Clalit Health Services
ClinicalTrials.gov Identifier:
NCT01654926
First received: July 29, 2012
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Heart Failure
 Procedure: blood ultrafiltration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility Assessment of the Aquadex FlexFlowTM Ultrafiltration System in Treating Non Hospitalized Heart Failure Patients in Dedicated Heart Failure Centers

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Clalit Health Services:

Estimated Enrollment: 60
Study Start Date: September 2012
Groups/Cohorts Assigned Interventions
Heart Failure patients Procedure: blood ultrafiltration

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HF patients

Criteria

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

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654926

Contacts
Contact: Ofer Amir, MD +972-4-8250658 offeram@clalit.org.il

Locations
Israel
Lin Clinic Not yet recruiting
Haifa, Israel
Contact: Ofer Amir, MD     +972-4-8250658     offeram@clalit.org.il    
Principal Investigator: Ofer Amir, MD            
Sponsors and Collaborators
Clalit Health Services
  More Information

No publications provided

Responsible Party: Dr. Ofer Amir, Head of the Lin Heart Failure Center, Clalit Health Services
ClinicalTrials.gov Identifier: NCT01654926     History of Changes
Other Study ID Numbers: UF-HF-1
Study First Received: July 29, 2012
Last Updated: July 31, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Clalit Health Services:
Feasibility of using the FlexFlowTM ultrafiltration pump in a non hospital environment

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013