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The Role of Peritoneal Dialysis in Patients With Refractory Heart Failure and Chronic Kidney Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Yonsei University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01758627
First Posted: January 1, 2013
Last Update Posted: February 19, 2014
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.
Information provided by (Responsible Party):
Yonsei University
December 24, 2012
January 1, 2013
February 19, 2014
December 2012
November 2015   (Final data collection date for primary outcome measure)
Changes of New York Heart Association (NYHA) functional class [ Time Frame: at 0 (±1 week), 12 (±1 week), and 24 (±1 week) weeks) ]
Same as current
Complete list of historical versions of study NCT01758627 on ClinicalTrials.gov Archive Site
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The Role of Peritoneal Dialysis in Patients With Refractory Heart Failure and Chronic Kidney Disease
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In patients with advanced heart failure (HF), systemic congestion is the main indication for hospitalization. Recent evidence has highlighted the role of fluid retention in the pathogenesis of renal dysfunction and subsequent diuretic resistance. Previous kidney disease, diuretic resistance, and progression of renal dysfunction often coexist in patients with HF and persistent volume overload. This clinical presentation represents the most extreme feature of the cardio-renal syndrome. However, available therapeutic options for this ominous condition are scarce and limited. Indeed, there are no data from randomized control trials using pharmacological interventions that support the beneficial effect on survival. Interestingly, intermittent ultrafiltration has recently emerged as an alternative therapeutic option for reducing volume overload in patients with refractory HF. Current literature suggests that it has potential advantages over standard medical treatment particularly in acute stages of HF. Among ultrafiltration methods, peritoneal dialysis (PD) has been preferred as an additional resource for the treatment of advanced congestive heart failure (CHF) compared with hemodialysis because it can provide a more physiological and continuous ultrafiltration. In fact, several studies showed that use of PD improved clinical functional class and hemodynamic parameters and reduced hospitalization rates in patients with CHF. Nevertheless, most studies were limited by retrospective analyses of small sample size, prospective observational design with no control group, or inclusion of patients with end-stage renal failure. Therefore, well-designed prospective randomized controlled studies are mandatory to confirm the effects of PD in these patients.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Refractory Heart Failure
  • Chronic Kidney Disease
Drug: Peritoneal dialysis (PD)
PD exchanges will be customized depending on patient fluid status. At least one daily exchange of icodextrin PD solution will be provided to PD group.
Other Name: PD exchanges will be customized depending on patient fluid status. At least one daily exchange of icodextrin PD solution will be provided to PD group.
  • No Intervention: Peritoneal dialysis group
  • Experimental: Conventional treatment group
    medical treatment such as diuretics
    Intervention: Drug: Peritoneal dialysis (PD)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
44
November 2016
November 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. At least two non-planned admissions for acute heart failure (AHF), the last episode being in the past 6 months
  2. New York Heart Association (NYHA) functional class III/IV and left ventricular ejection fraction (LVEF) less than 40%
  3. Persistent congestion despite optimal loop diuretic therapy
  4. Presence of renal dysfunction [estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2] documented at least once in the last 6 months

Exclusion Criteria:

  1. < 20 years of age
  2. Pregnancy
  3. Unsuitable for PD (patients with major abdominal wall defects)
  4. Allergic to starch or other contraindication to icodextrin (5) End-stage renal disease (eGFR < 10 ml/min/1.73 m2) requring dialysis treatment
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01758627
4-2012-0750
No
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Yonsei University
Yonsei University
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Yonsei University
February 2014

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