Study 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.
Peritoneal Dialysis in Congestive Heart Failure
PDinCHF
Symptomatic Improvement by Peritoneal Dialysis in Patients With End Stage Congestive Heart Failure
2 other identifiers
interventional
26
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2010
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 12, 2010
CompletedFirst Posted
Study publicly available on registry
May 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedAugust 16, 2019
August 1, 2019
6.4 years
May 12, 2010
August 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients in NYHA class I, II, III, or IV as measure of quality of life
8 months
Secondary Outcomes (1)
Quality of life measures
8 months
Study Arms (3)
Standard Care
SHAM COMPARATOR2 Icodextrin PD changes / day
ACTIVE COMPARATOR1 Icodextrin PD change/day
ACTIVE COMPARATORInterventions
2000 ml icodextrin intraperitoneally one or two times a day. Dose will be adapted clinically as in standard peritoneal dialysis.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Martini Hospital Groningenlead
- Baxter Healthcare Corporationcollaborator
- Roche BV Netherlandscollaborator
Study Sites (1)
Martini Hospital
Groningen, 9700 RM, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wilbert M Janssen, MD, PhD
Martini Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
May 12, 2010
First Posted
May 17, 2010
Study Start
April 1, 2010
Primary Completion
September 1, 2016
Study Completion
September 1, 2017
Last Updated
August 16, 2019
Record last verified: 2019-08