Peritoneal Dialysis in Congestive Heart Failure

Symptomatic Improvement by Peritoneal Dialysis in Patients With End Stage Congestive Heart Failure

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01124227

Acronym

PDinCHF

Enrollment

Registered

2010-05-17

Start date

2010-04-30

Completion date

2017-09-30

Last updated

2019-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure

Keywords

Congestive Heart Failure, Peritoneal Dialysis, Symptomatic improvement, Renal function

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).

Interventions

DRUGicodextrin

2000 ml icodextrin intraperitoneally one or two times a day. Dose will be adapted clinically as in standard peritoneal dialysis.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of patients in NYHA class I, II, III, or IV as measure of quality of life	8 months

Secondary

Measure	Time frame	Description
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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026