Peritoneal Dialysis in Congestive Heart Failure

Study Overview
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Brief Summary
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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).

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

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Drug: icodextrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Standard Care<br> | Drug: icodextrin<br>* 2000 ml icodextrin intraperitoneally one or two times a day. Dose will be adapted clinically as in standard peritoneal dialysis.<br>* Other names: RVG 21300;|
| Active Comparator: 2 Icodextrin PD changes / day<br> | Drug: icodextrin<br>* 2000 ml icodextrin intraperitoneally one or two times a day. Dose will be adapted clinically as in standard peritoneal dialysis.<br>* Other names: RVG 21300;|
| Active Comparator: 1 Icodextrin PD change/day<br> | Drug: icodextrin<br>* 2000 ml icodextrin intraperitoneally one or two times a day. Dose will be adapted clinically as in standard peritoneal dialysis.<br>* Other names: RVG 21300;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients in NYHA class I, II, III, or IV as measure of quality of life |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life measures | 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. | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congestive Heart Failure, Peritoneal Dialysis, Symptomatic improvement, Renal function