TerminatedPhase 3

Peritoneal Dialysis in Congestive Heart Failure

Stopped: Due to very specific inclusion criteria the anticipated number of patients was not reached. Inclusion stopped at N=26, allowing for analyzing primary outcomes.

Netherlands26 participantsStarted 2010-04

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 8 months

Trial details

NCT IDNCT01124227

SponsorMartini Hospital Groningen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09

View on ClinicalTrials.gov More Congestive Heart Failure trials