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Peritoneal Dialysis in Congestive Heart Failure (PDinCHF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01124227
Recruitment Status : Terminated (Due to very specific inclusion criteria the anticipated number of patients was not reached. Inclusion stopped at N=26, allowing for analyzing primary outcomes.)
First Posted : May 17, 2010
Last Update Posted : August 16, 2019
Sponsor:
Collaborators:
Baxter Healthcare Corporation
Roche BV Netherlands
Information provided by (Responsible Party):
Wilbert Martien Theodoor Janssen, Martini Hospital Groningen

Tracking Information
First Submitted Date  ICMJE May 12, 2010
First Posted Date  ICMJE May 17, 2010
Last Update Posted Date August 16, 2019
Study Start Date  ICMJE April 2010
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2010)
Number of patients in NYHA class I, II, III, or IV as measure of quality of life [ Time Frame: 8 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2010)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peritoneal Dialysis in Congestive Heart Failure
Official Title  ICMJE Symptomatic Improvement by Peritoneal Dialysis in Patients With End Stage Congestive Heart Failure
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Congestive Heart Failure
Intervention  ICMJE 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
Study Arms  ICMJE
  • Sham Comparator: Standard Care
    Intervention: Drug: icodextrin
  • Active Comparator: 2 Icodextrin PD changes / day
    Intervention: Drug: icodextrin
  • Active Comparator: 1 Icodextrin PD change/day
    Intervention: Drug: icodextrin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 15, 2019)
26
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2010)
45
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01124227
Other Study ID Numbers  ICMJE PDinCHF
2009-017711-15 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wilbert Martien Theodoor Janssen, Martini Hospital Groningen
Study Sponsor  ICMJE Martini Hospital Groningen
Collaborators  ICMJE
  • Baxter Healthcare Corporation
  • Roche BV Netherlands
Investigators  ICMJE
Principal Investigator: Wilbert M Janssen, MD, PhD Martini Hospital
PRS Account Martini Hospital Groningen
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP