Peritoneal Dialysis in Congestive Heart Failure (PDinCHF)

Due to very specific inclusion criteria the anticipated number of patients was not reached. Inclusion stopped at N=26, allowing for analyzing primary outcomes.

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).

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

Reduction in unfavorable days. Short-Form 36. Minnesota Living with Heart failure Questionnaire. 6 minute walk test. (re)hospitalization. Survival. Medication optimalisation. Cardial: LVH. Renal: GFR/ERPF/FF; KIM-1, NGAL, NAG. Volume status: ECV (radioactive and bio-impedance). Neurohumoral and inflammatory parameters.

Inclusion Criteria: Age > 18 years 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: Hypotension (SBP < 100 mmHg / MAP < 70) mmHg 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