Peritoneal Dialysis in Congestive Heart Failure (PDinCHF)

Martini Hospital Groningen

Status and phase: Terminated; Phase 3

Conditions: Congestive Heart Failure

Treatments: Drug: icodextrin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01124227

2009-017711-15 (EudraCT Number)

PDinCHF

Details and patient eligibility

About

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).

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 3 patient groups

Standard Care

Sham Comparator group

Treatment:

Drug: icodextrin

2 Icodextrin PD changes / day

Active Comparator group

Treatment:

Drug: icodextrin

1 Icodextrin PD change/day

Active Comparator group

Treatment:

Drug: icodextrin