Peritoneal Dialysis in Congestive Heart Failure (PDinCHF)

August 15, 2019 updated by: Wilbert Martien Theodoor Janssen, Martini Hospital Groningen

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700 RM
        • Martini Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Standard Care
Drug: icodextrin
2000 ml icodextrin intraperitoneally one or two times a day. Dose will be adapted clinically as in standard peritoneal dialysis.
Other Names:
  • Extraneal
  • RVG 21300
Active Comparator: 2 Icodextrin PD changes / day
Drug: icodextrin
2000 ml icodextrin intraperitoneally one or two times a day. Dose will be adapted clinically as in standard peritoneal dialysis.
Other Names:
  • Extraneal
  • RVG 21300
Active Comparator: 1 Icodextrin PD change/day
Drug: icodextrin
2000 ml icodextrin intraperitoneally one or two times a day. Dose will be adapted clinically as in standard peritoneal dialysis.
Other Names:
  • Extraneal
  • RVG 21300

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life measures
Time Frame: 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.
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martini Hospital Groningen

Collaborators

Baxter Healthcare Corporation
Roche BV Netherlands

Investigators

  • Principal Investigator: Wilbert M Janssen, MD, PhD, Martini Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

May 12, 2010

First Submitted That Met QC Criteria

May 14, 2010

First Posted (Estimate)

May 17, 2010

Study Record Updates

Last Update Posted (Actual)

August 16, 2019

Last Update Submitted That Met QC Criteria

August 15, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDinCHF
  • 2009-017711-15 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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