Heart FailureAquadexNCT02079259
CVP-guided Aquapheresis for the Treatment of Acute Congestion in Heart Failure
An observational study of Heart Failure, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial 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. 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?
- Ultrafiltration
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Mar 2014
- 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: Patients with chronic heart failure listed for LVAD
Who may be able to join
- Patients with chronic heart failure scheduled for LVAD
- Indication for CVVH/Aquapheresis
Who cannot join
- Renal Disease (GFR <20 ml / min)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf
Düsseldorf
About this study
Official title: 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
- Conditions
- Heart Failure
- Being tested
- Ultrafiltration
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrafiltrationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in central venous pressure
Measured: Changes from Baseline to 48 h after intervention
Secondary outcomes (8)
amount of net fluid loss
Measured: 48 h
Measure of dyspnea using a visual analog scale
Measured: Changes from Baseline to 48 h after intervention
heart function
right/left heart function measured by Echocardiography and BNP (Brain Natriuretic Peptide)
Measured: 7 days
Biomarker
GFR, Cystatin C, HCO3-, NT-proBNP, CK, Troponin, Hematocrit
Measured: Changes from Baseline to 48 h after intervention
Time until impaired plasma refill rate
Measured: 48 h
blood pressure
Measured: Changes from Baseline to 48 h after intervention
heart rate
Measured: Changes from Baseline to 48 h after intervention
Serum Creatinine level
Measured: 48 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startNov 2013
- Primary completionMar 2014
- Study completionMar 2014
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.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Ralf Westenfeld, MD, Principal investigator, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital DusseldorfMalte Kelm, MD, Study chair, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079259
- Sponsor's protocol ID
- Aquadex
- Acronym
- Aquadex
- Status last verified
- Mar 2015
- First submitted
- 28 Feb 2014
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CVP-guided Aquapheresis for the Treatment of Acute Congestion in Heart Failure - A Pilot Study to Optimize Individualized Volume Depletion
- ClinicalTrials.gov ID
- NCT02079259
- Acronym / sponsor ID
- Aquadex / Aquadex
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 5 Mar 2014 (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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic heart failure listed for LVAD
Key inclusion criteria (2 listed)
- Patients with chronic heart failure scheduled for LVAD
- Indication for CVVH/Aquapheresis
Key exclusion criteria (1 listed)
- Renal Disease (GFR <20 ml / min)
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 |
|---|---|---|
| Ultrafiltration | Procedure or surgery | – |
Primary outcome
Changes in central venous pressure
Time frame: Changes from Baseline to 48 h after intervention
8 secondary outcomes
amount of net fluid loss
Time frame: 48 h
Measure of dyspnea using a visual analog scale
Time frame: Changes from Baseline to 48 h after intervention
heart function
Time frame: 7 days
Biomarker
Time frame: Changes from Baseline to 48 h after intervention
Time until impaired plasma refill rate
Time frame: 48 h
blood pressure
Time frame: Changes from Baseline to 48 h after intervention
heart rate
Time frame: Changes from Baseline to 48 h after intervention
Serum Creatinine level
Time frame: 48 h
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 17 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.
Ralf Westenfeld, MD principal investigator
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf
Malte Kelm, MD study chair
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf
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 Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 2 inclusion and 1 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 17 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 Germany. 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?
Changes in central venous pressure (time frame: Changes from Baseline to 48 h after intervention). 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 17 Mar 2015.