Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
26 participants
INTERVENTIONAL
2010-04-30
2017-09-30
Brief Summary
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Objective: To improve symptomatology in severe chronic failure patients. Study design: Open, parallel intervention trial comparing 2 schemes of peritoneal dialysis with icodextrin (Extraneal®) with standard medical therapy..
Study population: Patients with chronic refractory left ventricular congestive heart failure (LVEF \< 30%, older than 18 years).
Intervention: Peritoneal dialysis with one (night) or two (night and day) dwells with icodextrin (Extraneal®).
Main study parameters/endpoints: Reduction in NYHA classification of symptomatic Congestive Heart Failure at 8 months after start of PD therapy. Burden of congestive heart failure: measured by reduction in unfavorable days (noted by patients in diaries and including days of hospitalization for CHF-deterioration and death).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Care
icodextrin
2000 ml icodextrin intraperitoneally one or two times a day. Dose will be adapted clinically as in standard peritoneal dialysis.
2 Icodextrin PD changes / day
icodextrin
2000 ml icodextrin intraperitoneally one or two times a day. Dose will be adapted clinically as in standard peritoneal dialysis.
1 Icodextrin PD change/day
icodextrin
2000 ml icodextrin intraperitoneally one or two times a day. Dose will be adapted clinically as in standard peritoneal dialysis.
Interventions
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icodextrin
2000 ml icodextrin intraperitoneally one or two times a day. Dose will be adapted clinically as in standard peritoneal dialysis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Refractory Left Ventricular Congestive Heart Failure: LVEF \< 30%
* Diminished renal function: eGFR \< 60 ml/min
* Clinically volume overloaded (Dyspnoea (NYHA III-IV), edema, and/or ascites)
* Hospitalization for CHF during the last 6 months
* Patient is on optimal cardiologic medical therapy, which has been stable for more than 4 weeks
* Suitable for PD
Exclusion Criteria
* Instable AP or recent (\< 6 months) myocardial infarction.
* Contraindications for PD (e.g. visual handicap, social)
* Liver failure
* COPD Gold class IV
* Malignancy with life expectancy \< 2 years
* Non compliance
* No informed consent
* Poor mental health
18 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Roche BV Netherlands
UNKNOWN
Martini Hospital Groningen
OTHER
Responsible Party
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Wilbert Martien Theodoor Janssen
MD PhD
Principal Investigators
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Wilbert M Janssen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Martini Hospital
Locations
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Martini Hospital
Groningen, , Netherlands
Countries
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Other Identifiers
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2009-017711-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PDinCHF
Identifier Type: -
Identifier Source: org_study_id
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