Peritoneal Dialysis in Congestive Heart Failure
- Registration Number
- NCT01124227
- Lead Sponsor
- Martini Hospital Groningen
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 26
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Care icodextrin - 2 Icodextrin PD changes / day icodextrin - 1 Icodextrin PD change/day icodextrin -
- Primary Outcome Measures
Name Time Method Number of patients in NYHA class I, II, III, or IV as measure of quality of life 8 months
- Secondary Outcome Measures
Name Time Method Quality of life measures 8 months 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.
Trial Locations
- Locations (1)
Martini Hospital
🇳🇱Groningen, Netherlands