Congestive Heart FailureNCT00907673
The Automated Fluid Shunt (AFS)in Chronic Congestive Heart Failure
A study testing Automatic Fluid Shunt System in people with Congestive Heart Failure and Ascites, run by NovaShunt AG at 1 site in Sweden.
Trial summary
A 28-week, feasibility study to investigate the safety and efficiency of the Automatic Fluid Shunt in patients with chronic congestive heart failure, ascites and diuretic resistance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Ascites
- What is being tested?
- Automatic Fluid Shunt System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSweden
- Study dates
- May 2009to Mar 2010
- Phase
- Interventional
- 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
Who may be able to join
- Female or male patients ≥ 18 years of age
- A clinical diagnosis of chronic congestive heart failure > 6 months
- At least one episode of documented ADHF during the previous 6 months
- NYHA functional class III-IV
- Circulating levels of NT-proBNP ≥ 800 ng/L.
- Stable, optimized therapy for heart failure for at least 4 weeks prior to enrollment
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- Echocardiography performed within 3 months
- Detectable ascites by ultrasound and/or computed tomography
- Diuretic resistance defined as a daily dose of furosemide > 80 mg, torsemide > 40 mg or bumetanide > 2 mg
- Written informed consent
Who cannot join
- Present or recurring systemic or local infection, such as peritonitis, urinary tract infection, or abdominal skin infection.
- Ongoing malignant disease with adverse prognosis
- Evidence of firmly loculated peritoneal effusion.
- Obstructive uropathy
- Severely reduced renal function (S-Creatinine 300 mol/l) or end-stage renal disease requiring dialysis
- Severe liver disease (ASAT and/or ALAT and/or total bilirubin three times upper limit of normal range laboratory values)
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- Pregnancy
- Requirement for intravenous inotropes
- Acute coronary syndrome or any condition requiring emergency treatment
- Heart disease requiring surgical intervention during the course of the study
- Any other clinically significant disease that could be adversely affected by study participation judged by the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
A 28-week, feasibility study to investigate the safety and efficiency of the Automatic Fluid Shunt in patients with chronic congestive heart failure, ascites and diuretic resistance.
- Conditions
- Congestive Heart Failure, Ascites
- Being tested
- Automatic Fluid Shunt System
- Medical subject headings
- Heart Failure, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic Fluid Shunt SystemDevice
Also called AFS System
Fully implantable peritoneal catheter, bladder catheter, and pump
| Study group | Role | What they receive |
|---|---|---|
| Patient condition pre-implant | Active comparator | Not described Receives: Device: Automatic Fluid Shunt System |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety of the Automated Fluid Shunt device during a 28-week follow-up and to evaluate its efficacy by measuring change in NT-proBNP from baseline to 16 weeks, in patients with chronic congestive heart failure, ascites and diuretic resistance.
Measured: 16 and 28 weeks
Secondary outcomes (5)
To determine the effect of AFS-treatment on functional capacity (NYHA class and 6-min. walking distance) compared from baseline to 16 and 28 weeks
Measured: 16 and 28 weeks
To determine change in LV volumes and LVEF (echocardiography) compared from baseline to 16 and 28 weeks
Measured: 16 and 28 weeks
To determine change in ascites, hydrothorax and leg edema (based on CT evaluation) compared from baseline to 16 and 28 weeks
Measured: 16 and 28 weeks
To determine change in renal function (GFR) compared from baseline to 16 and 28 weeks
Measured: 16 and 28 weeks
To determine change in quality of life based on Minnesota Living with Heart Failure Questionnaire (MLHFQ) compared from baseline to 4, 12 and 28 weeks
Measured: baseline to 4, 12 and 28 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startMay 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovaShunt AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristjan Karason, MD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907673
- Sponsor's protocol ID
- 2008-CHF-001
- Status last verified
- Dec 2011
- First submitted
- 21 May 2009
- Last updated
- 19 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Automated Fluid Shunt (AFS)in Chronic Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00907673
- Acronym / sponsor ID
- 2008-CHF-001
- Conditions
- Congestive Heart Failure, Ascites
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- NovaShunt AGIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 22 May 2009 (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.
A 28-week, feasibility study to investigate the safety and efficiency of the Automatic Fluid Shunt in patients with chronic congestive heart failure, ascites and diuretic resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient condition pre-implant | Active comparator | Device: Automatic Fluid Shunt System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female or male patients ≥ 18 years of age
- A clinical diagnosis of chronic congestive heart failure > 6 months
- At least one episode of documented ADHF during the previous 6 months
- NYHA functional class III-IV
- Circulating levels of NT-proBNP ≥ 800 ng/L.
Key exclusion criteria (11 listed)
- Present or recurring systemic or local infection, such as peritonitis, urinary tract infection, or abdominal skin infection.
- Ongoing malignant disease with adverse prognosis
- Evidence of firmly loculated peritoneal effusion.
- Obstructive uropathy
- Severely reduced renal function (S-Creatinine 300 mol/l) or end-stage renal disease requiring dialysis
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 |
|---|---|---|
| Automatic Fluid Shunt SystemAlso: AFS SystemFully implantable peritoneal catheter, bladder catheter, and pump | Device | Patient condition pre-implant |
Primary outcome
To evaluate safety of the Automated Fluid Shunt device during a 28-week follow-up and to evaluate its efficacy by measuring change in NT-proBNP from baseline to 16 weeks, in patients with chronic congestive heart failure, ascites and diuretic resistance.
Time frame: 16 and 28 weeks
5 secondary outcomes
To determine the effect of AFS-treatment on functional capacity (NYHA class and 6-min. walking distance) compared from baseline to 16 and 28 weeks
Time frame: 16 and 28 weeks
To determine change in LV volumes and LVEF (echocardiography) compared from baseline to 16 and 28 weeks
Time frame: 16 and 28 weeks
To determine change in ascites, hydrothorax and leg edema (based on CT evaluation) compared from baseline to 16 and 28 weeks
Time frame: 16 and 28 weeks
To determine change in renal function (GFR) compared from baseline to 16 and 28 weeks
Time frame: 16 and 28 weeks
To determine change in quality of life based on Minnesota Living with Heart Failure Questionnaire (MLHFQ) compared from baseline to 4, 12 and 28 weeks
Time frame: baseline to 4, 12 and 28 week
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 19 Dec 2011.
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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.
Kristjan Karason, MD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automatic Fluid Shunt System in people with Congestive Heart Failure and Ascites, run by NovaShunt AG at 1 site in Sweden.
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 10 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 19 Dec 2011. 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 Sweden. 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?
To evaluate safety of the Automated Fluid Shunt device during a 28-week follow-up and to evaluate its efficacy by measuring change in NT-proBNP from baseline to 16 weeks, in patients with chronic congestive heart failure, ascites and diuretic resistance. (time frame: 16 and 28 weeks). 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 19 Dec 2011.