The Role of Peritoneal Dialysis in Patients With Refractory Heart Failure and Chronic Kidney Disease
Primary Purpose
Refractory Heart Failure, Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Peritoneal dialysis (PD)
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Heart Failure focused on measuring Peritoneal dialysis,, chronic kidney disease,, refractory heart failure
Eligibility Criteria
Inclusion Criteria:
- At least two non-planned admissions for acute heart failure (AHF), the last episode being in the past 6 months
- New York Heart Association (NYHA) functional class III/IV and left ventricular ejection fraction (LVEF) less than 40%
- Persistent congestion despite optimal loop diuretic therapy
- 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:
- < 20 years of age
- Pregnancy
- Unsuitable for PD (patients with major abdominal wall defects)
- Allergic to starch or other contraindication to icodextrin (5) End-stage renal disease (eGFR < 10 ml/min/1.73 m2) requring dialysis treatment
Sites / Locations
- Division of Nephrology, Department of Internal Medicine Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Peritoneal dialysis group
Conventional treatment group
Arm Description
medical treatment such as diuretics
Outcomes
Primary Outcome Measures
Changes of New York Heart Association (NYHA) functional class
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01758627
Brief Title
The Role of Peritoneal Dialysis in Patients With Refractory Heart Failure and Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
October 8, 2015 (Actual)
Study Completion Date
October 8, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Heart Failure, Chronic Kidney Disease
Keywords
Peritoneal dialysis,, chronic kidney disease,, refractory heart failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peritoneal dialysis group
Arm Type
No Intervention
Arm Title
Conventional treatment group
Arm Type
Experimental
Arm Description
medical treatment such as diuretics
Intervention Type
Drug
Intervention Name(s)
Peritoneal dialysis (PD)
Other Intervention Name(s)
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.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes of New York Heart Association (NYHA) functional class
Time Frame
at 0 (±1 week), 12 (±1 week), and 24 (±1 week) weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least two non-planned admissions for acute heart failure (AHF), the last episode being in the past 6 months
New York Heart Association (NYHA) functional class III/IV and left ventricular ejection fraction (LVEF) less than 40%
Persistent congestion despite optimal loop diuretic therapy
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:
< 20 years of age
Pregnancy
Unsuitable for PD (patients with major abdominal wall defects)
Allergic to starch or other contraindication to icodextrin (5) End-stage renal disease (eGFR < 10 ml/min/1.73 m2) requring dialysis treatment
Facility Information:
Facility Name
Division of Nephrology, Department of Internal Medicine Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Role of Peritoneal Dialysis in Patients With Refractory Heart Failure and Chronic Kidney Disease
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