Overview
Peritoneal Dialysis in Congestive Heart Failure
Status:
Terminated
Terminated
Trial end date:
2017-09-01
2017-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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).Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Martini Hospital GroningenCollaborators:
Baxter Healthcare CorporationRoche BV Netherlands
Treatments:
IcodextrinCriteria
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