Peritoneal Ultrafiltration in Cardio Renal Syndrome. (PURE)
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|ClinicalTrials.gov Identifier: NCT03994874|
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Congestive Heart Failure||Drug: PolyCore (Polydextrin, L-Carnitine, D-xylitol) Drug: Medical therapy including loop diuretic (furosemide) daily dose up to 2.5 mg/kg/day,||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be assigned randomly to receive either PolyCore PUF (over the top of their prescribed heart failure medications), for 6 months, or to the control arm receiving no PUF therapy.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||A blinded independent review committee, comprised of experienced cardiologist and nephrologists, who are non-participating investigators in this study, will be appointed to confirm the primary end-point.|
|Official Title:||Peritoneal Ultrafiltration in Cardio Renal Syndrome to Prevent Heart Failure Exacerbation.|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||October 2021|
Experimental: PolyCore PUF
PolyCore peritoneal ultrafiltration (PUF) (over the top of patient's prescribed heart failure medications), for 6 months.
Drug: PolyCore (Polydextrin, L-Carnitine, D-xylitol)
A single nightly exchange, with 2 liters PolyCore solution, lasting 12-14 hours. Patients should remain on their prescribed heart failure medications and the same dosing schedule for the duration of the study unless investigators determine medically necessary to change.
Other Name: PolyCore peritoneal dialysis solution
Active Comparator: Control
Patients in the control arm (receiving no PUF therapy) will remain on their prescribed heart failure medications.
Drug: Medical therapy including loop diuretic (furosemide) daily dose up to 2.5 mg/kg/day,
During the study, patients should remain on their prescribed heart failure medications and the same dosing schedule for the duration of the study unless investigators determine medically necessary to change.
Other Name: Guidelines directed medical therapy
- Composite end-point of mortality and worsening patient's condition [ Time Frame: Up to 6 months ]
- patient's mortality - or
- the need of increasing of ≥50% the initial daily dose of loop diuretic - or
- the hospitalization for infusional therapy with loop diuretic based on the lack of adequate response to maximal dose of oral furosemide (>2.5 mg/kg/day) - or
- requiring other methods of treatment [i.e. PUF or hemodialysis], based on persistence of high venous congestion (detected with central venous pressure measurement: >8 mm Hg or dilated inferior cava vein, without respiratory change, measured with focused abdominal echography, and coupled with body weight increase of 1 kg or more in the last 24 hrs.
- 6 min Walking distance [ Time Frame: At 3 and 6 months ]Change from the baseline
- Quality of life tested with Minnesota Living with Heart Failure Questionnaire [ Time Frame: At 3 and 6 months ]Change from the baseline
- Number of patients with decrease of NT pro-BNP (N-terminal pro brain natriuretic peptide) [ Time Frame: At 3 and 6 months ]The number of patients with a decrease in NT pro-BNP level of ≥25% from baseline
- Worsening of renal function [ Time Frame: Up to 6 months ]Estimated Glomerular Filtration Rate (eGFR) ≤20 ml/min
- Cumulative daily dosage of loop diuretic [ Time Frame: 6 months ]Change over the 6 months of study treatment,
- Use of hospital resources [ Time Frame: 6 months ]The number of days spent in-hospital because of HF exacerbation during the 6 months of study treatment
- New York Heart Association (NYHA) class [ Time Frame: At 1, 3 and 6 months ]Change from baseline
- Number of patients requiring hospitalization [ Time Frame: 6 months ]Hospitalization for infusional therapy with loop diuretic
- Number of patients increasing of ≥50% the initial daily dose of loop diuretic [ Time Frame: 6 months ]Change from baseline
- Adverse Events [ Time Frame: 6 months ]Information about all adverse events, whether volunteered by the patient, discovered by investigator questioning, or detected through physical examination, laboratory or instrumental test, will be collected, recorded and followed as appropriate.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994874
|Contact: Arduino Arduini, MD||+41 79 firstname.lastname@example.org|
|Study Director:||Edoardo Gronda, MD||Policlinico Milano|