NCT01124227

Peritoneal Dialysis in Congestive Heart Failure

Symptomatic Improvement by Peritoneal Dialysis in Patients With End Stage Congestive Heart Failure

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Martini Hospital Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Timeline

• Start date: 2010-04-01
• Primary completion: 2016-09-01
• Completion: 2017-09-01
• First posted: 2010-05-17
• Last updated: 2019-08-16

Locations

1 site across 1 country: Netherlands