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Peritoneal Dialysis in Congestive Heart Failure

NCT01124227 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-08-16

No results posted yet for this study

Summary

Rationale: End-stage congestive heart failure is a serious invalidating condition with a poor prognosis and increasing incidence. Non-randomized observations showed peritoneal dialysis (PD) in these patients to improve clinically from NYHA stadium III-IV to as low as NYHA stadium I-II. A randomized trial is needed to test whether PD improves symptoms in this condition and to find an optimal scheme.

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).

Conditions

  • Congestive Heart Failure

Interventions

DRUG

icodextrin

2000 ml icodextrin intraperitoneally one or two times a day. Dose will be adapted clinically as in standard peritoneal dialysis.

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Roche BV Netherlands

    collaborator UNKNOWN

  • Martini Hospital Groningen

    lead OTHER

Principal Investigators

  • Wilbert M Janssen, MD, PhD · Martini Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2016-09-30
Completion
2017-09-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01124227 on ClinicalTrials.gov