Heart FailureNCT01654926
Feasibility Assessment of the Aquadex FlexFlowTM Ultrafiltration System in Treating Non Hospitalized Heart Failure Patients in Dedicated Heart Failure Centers
An observational study of Heart Failure, run by Clalit Health Services at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- blood ultrafiltration
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2012to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HF patients
Who may be able to join
- HF patients with peripheral or pulmonic fluid retention, with little or no response to Diuretics as defined by the referring cardiologist
Who cannot join
- Age < 18 years
- Patient does not fully comprehend the Essence of the study and can not sign the informed consent.
- Patient is participating in a drug or any other treatment study (no prevention to include patients participating in studies of non invasive monitoring technologies.
- Presence of Acute MI
- CR base values > 3mg/dl
- Hemodynamic instability requiring Inotropic agents
Show all 11Show fewer
- HT base values > 45%
- Known pregnancy
- Presence of contraindication to anticoagulants
- Post heart transplant or cardiac assist device implantation
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- blood ultrafiltration
- Keywords
- Feasibility of using the FlexFlowTM ultrafiltration pump in a non hospital environment
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood ultrafiltrationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure patients | Not described Receives: Procedure: blood ultrafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Assessment of the Aquadex FlexFlowTM Ultrafiltration System in Treating Non-Hospitalized Heart Failure Patients in Dedicated Heart Failure Centers
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ofer Amir, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654926
- Sponsor's protocol ID
- UF-HF-1
- Status last verified
- Mar 2015
- First submitted
- 29 Jul 2012
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Assessment of the Aquadex FlexFlowTM Ultrafiltration System in Treating Non Hospitalized Heart Failure Patients in Dedicated Heart Failure Centers
- ClinicalTrials.gov ID
- NCT01654926
- Acronym / sponsor ID
- UF-HF-1
- Conditions
- Heart Failure
- Keywords
- Feasibility of using the FlexFlowTM ultrafiltration pump in a non hospital environment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 1 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure patients | – | Procedure: blood ultrafiltration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HF patients
Key inclusion criteria (1 listed)
- HF patients with peripheral or pulmonic fluid retention, with little or no response to Diuretics as defined by the referring cardiologist
Key exclusion criteria (11 listed)
- Age < 18 years
- Patient does not fully comprehend the Essence of the study and can not sign the informed consent.
- Patient is participating in a drug or any other treatment study (no prevention to include patients participating in studies of non invasive monitoring technologies.
- Presence of Acute MI
- CR base values > 3mg/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood ultrafiltration | Procedure or surgery | Heart Failure patients |
Primary outcome
Feasibility Assessment of the Aquadex FlexFlowTM Ultrafiltration System in Treating Non-Hospitalized Heart Failure Patients in Dedicated Heart Failure Centers
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Clalit Health Services at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Assessment of the Aquadex FlexFlowTM Ultrafiltration System in Treating Non-Hospitalized Heart Failure Patients in Dedicated Heart Failure Centers (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.