Rationale and design of the MASTERPLAN study: Multifactorial approach and superior treatment efficacy in renal patients with the aid of nurse practitioners

Department of Nephrology and Hypertension, University Medical Center Utrecht-The Netherlands.
Journal of nephrology (Impact Factor: 1.45). 01/2005; 18(1):30-4.
Source: PubMed


BACKGROUND: Chronic kidney disease (CKD) is an established risk factor for cardiovascular disease (CVD). In addition, patients with renal disease are exposed to a myriad of risk factors that increase their risk even further. The treatment of risk factors in these patients is paramount to reducing cardiovascular risk and for attenuating renal failure progression. It is well known that lifestyle interventions are difficult, and that medical treatment targets are seldom met. A multifactorial approach with the aid of nurse practitioners has shown to be beneficial for achieving treatment goals and reducing events in patients with diabetes mellitus and with heart failure. We propose that this will also hold for the CKD population. TRIAL DESIGN: A multicenter randomized clinical trial will be performed to study whether intensive medical care delivered by a nurse practitioner and a nephrologist will reduce cardiovascular risk compared to care provided by the nephrologist alone. The acronym MASTERPLAN describes the study: Multifactorial approach and superior treatment efficacy in renal patients with the aid of nurse practitioners. Eight hundred patients will be randomized to physician care or nurse practitioner support. For all patients the same set of guidelines and treatment goals will apply. Both groups will receive treatment according to current guidelines and have access to specific cardioprotective medication. Nurse practitioners will intensify therapy by promoting lifestyle intervention, and meticulous implementation of relevant guidelines. Patients will be followed-up for 5 yrs after baseline. Primary endpoints are all-cause mortality, cardiovascular morbidity and cardiovascular mortality.

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    • "The MASTERPLAN (Multifactorial Approach and Superior Treatment Efficacy in Renal Patients with the Aid of Nurse practitioners) study [Trial registration ISRCTN registry: 73187232] is a randomized controlled trial conducted in nine centers with a nephrology department in The Netherlands, evaluating the added value of nurse practitioner care in reducing cardiovascular events and attenuating kidney function decline in patients with prevalent CKD. Rationale and design have been published elsewhere [22,23]. Ethics committee approval was obtained as well as written informed consent of all participants. "
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    ABSTRACT: Transparency in quality of care (QoC) is stimulated and hospitals are compared and judged on the basis of indicators of performance on specific treatment targets. In patients with chronic kidney disease, QoC differed significantly between hospitals. In this analysis we explored additional parameters to explain differences between centers in attainment of parathyroid hormone (PTH) treatment targets. Using MASTERPLAN baseline data, we selected one of the worst (center A) and one of the best (center B) performing hospitals. Differences between the two centers were analyzed from the year prior to start of the MASTERPLAN study until the baseline evaluation. Determinants of PTH were assessed. 101 patients from center A (median PTH 9.9 pmol/l, in 67 patients exceeding recommended levels) and 100 patients from center B (median PTH 6.5 pmol/l, in 34 patients exceeding recommended levels), were included. Analysis of clinical practice did not reveal differences in PTH management between the centers. Notably, hyperparathyroidism resulted in a change in therapy in less than 25% of patients. In multivariate analysis kidney transplant status, MDRD-4, and treatment center were independent predictors of PTH. However, when MDRD-6 (which accounts for serum urea and albumin) was used instead of MDRD-4, the center effect was reduced. Moreover, after calibration of the serum creatinine assays treatment center no longer influenced PTH. We show that differences in PTH control between centers are not explained by differences in treatment, but depend on incomparable patient populations and laboratory techniques. Therefore, results of hospital performance comparisons should be interpreted with great caution.
    BMC Nephrology 08/2012; 13(1):82. DOI:10.1186/1471-2369-13-82 · 1.69 Impact Factor
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    • "For the current study patients from the MASTERPLAN study were used [10]. The MASTERPLAN study was centrally approved by the medical ethical committee of UMCU (METC, University medical center Utrecht), and locally by all participating centers. "
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    ABSTRACT: Fibroblast growth factor 23 (FGF23) has emerged as a risk factor for cardiovascular disease and mortality throughout all stages of chronic kidney disease (CKD), independent from established risk factors and markers of mineral homeostasis. The relation of FGF23 with other renal and non-renal cardiovascular risk factors is not well established. Using stored samples, plasma FGF23 was determined in 604 patients with moderate to severe kidney disease that participated in the MASTERPLAN study (ISRCTN73187232). The association of FGF23 with demographic and clinical parameters was evaluated using multivariable regression models. Mean age in the study population was 60 years and eGFR was 37 (± 14) ml/min/1.73 m(2). Median proteinuria was 0.3 g/24 hours [IQR 0.1-0.9]. FGF23 level was 116 RU/ml [67-203] median and IQR. Using multivariable analysis the natural logarithm of FGF23 was positively associated with history of cardiovascular disease (B = 0.224 RU/ml; p = 0.002), presence of diabetes (B = 0.159 RU/ml; p = 0.035), smoking (B = 0.313 RU/ml; p < 0.001), phosphate level (B = 0.297 per mmol/l; p = 0.0024), lnPTH (B = 0.244 per pmol/l; p < 0.001) and proteinuria (B = 0.064 per gram/24 hrs; p = 0.002) and negatively associated with eGFR (B = -0.022 per ml/min/1.73 m(2); p < 0.001). Our study demonstrates that in patients with CKD, FGF23 is related to proteinuria and smoking. We confirm the relation between FGF23 and other cardiovascular risk factors.
    BMC Nephrology 04/2012; 13(1):20. DOI:10.1186/1471-2369-13-20 · 1.69 Impact Factor
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    ABSTRACT: Increased activities of the renin system and the sympathetic nervous system are key contributors to the pathogenesis of hypertension in chronic kidney disease patients. Eprosartan is an angiotensin II receptor antagonist, which effectively reduces muscle sympathetic nerve activity (MSNA) in chronic kidney disease patients.
    Journal of Clinical and Basic Cardiology 01/2006; 9(1).
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