Congestive Heart Failure Clinical Trial
Official title:
Symptomatic Improvement by Peritoneal Dialysis in Patients With End Stage Congestive Heart Failure
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).
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