Peritoneal Dialysis in Congestive Heart Failure (PDinCHF)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Martini Hospital Groningen.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014