Peritoneal Dialysis in Congestive Heart Failure

Phase 3TerminatedNCT01124227

Martini Hospital Groningen26 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Congestive Heart Failure

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of patients in NYHA class I, II, III, or IV as measure of quality of life

Time frame: 8 months

Secondary Outcomes

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.