The Role of Peritoneal Dialysis in Patients With Refractory Heart Failure and Chronic Kidney Disease
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.
Refractory Heart Failure
Chronic Kidney Disease
Drug: Peritoneal dialysis (PD)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- Changes of New York Heart Association (NYHA) functional class [ Time Frame: at 0 (±1 week), 12 (±1 week), and 24 (±1 week) weeks) ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
|No Intervention: Peritoneal dialysis group|
Experimental: Conventional treatment group
medical treatment such as diuretics
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.
|Contact: Seung Hyeok Han, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Division of Nephrology, Department of Internal Medicine Yonsei University College of Medicine||Not yet recruiting|
|Seoul, Korea, Republic of, 120-752|
|Contact: Seung Hyeok Han, M.D., Ph,D 82-2-22281975 email@example.com|