Clinical trial NCT00907673: The Automated Fluid Shunt (AFS)in Chronic Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Ascites
Lead sponsor: NovaShunt AG
Sponsor class: INDUSTRY
First posted: 2009-05-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
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.
timeFrame: 16 and 28 weeks
Secondary outcomes:
measure: 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
timeFrame: 16 and 28 weeks
measure: To determine change in LV volumes and LVEF (echocardiography) compared from baseline to 16 and 28 weeks
timeFrame: 16 and 28 weeks
measure: To determine change in ascites, hydrothorax and leg edema (based on CT evaluation) compared from baseline to 16 and 28 weeks
timeFrame: 16 and 28 weeks
measure: To determine change in renal function (GFR) compared from baseline to 16 and 28 weeks
timeFrame: 16 and 28 weeks
measure: 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
timeFrame: baseline to 4, 12 and 28 week
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Kristjan Karason, MD
role: PRINCIPAL_INVESTIGATOR
References: