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Peritoneal Dialysis in Congestive Heart Failure (PDinCHF)

This study is currently recruiting participants.
Verified January 2012 by Martini Hospital Groningen
Sponsor:
Collaborators:
Baxter Healthcare Corporation
Roche BV Netherlands
Information provided by (Responsible Party):
Wilbert Martien Theodoor Janssen, Martini Hospital Groningen
ClinicalTrials.gov Identifier:
NCT01124227
First received: May 12, 2010
Last updated: January 4, 2012
Last verified: January 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Congestive Heart Failure
 Drug: icodextrin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Symptomatic Improvement by Peritoneal Dialysis in Patients With End Stage Congestive Heart Failure

Resource links provided by NLM:

Drug Information available for: Icodextrin
U.S. FDA Resources

Further study details as provided by Martini Hospital Groningen:

Primary Outcome Measures:
  • Number of patients in NYHA class I, II, III, or IV as measure of quality of life [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life measures [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 45
Study Start Date: April 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124227

Contacts
Contact: Wilbert M Janssen, MD, PhD +31-50-5247911 w.m.t.janssen@mzh.nl
Contact: Femke Waanders, MD, PhD +31-50-5247761 f.waanders@mzh.nl

Locations
Netherlands
Martini Hospital Recruiting
Groningen, Netherlands, 9700 RM
Principal Investigator: Wilbert M Janssen, MD, PhD            
Sub-Investigator: Femke Waanders, MD, PhD            
Sub-Investigator: Jan Posma, MD, PhD            
Sponsors and Collaborators
Martini Hospital Groningen
Baxter Healthcare Corporation
Roche BV Netherlands
Investigators
Principal Investigator: Wilbert M Janssen, MD, PhD Martini Hospital
  More Information

No publications provided

Responsible Party: Wilbert Martien Theodoor Janssen, MD PhD, Martini Hospital Groningen
ClinicalTrials.gov Identifier: NCT01124227     History of Changes
Other Study ID Numbers: PDinCHF, 2009-017711-15
Study First Received: May 12, 2010
Last Updated: January 4, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Martini Hospital Groningen:
Congestive Heart Failure
Peritoneal Dialysis
Symptomatic improvement
Renal function

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013