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Prevention of cardiovascular disease and progression of renal failure in patients with chronic renal insufficiency: implementation of maximal endothelial protection with the aid of nurse practitioners. A randomized multi-center study.


- candidate number0
- NTR NumberNTR22
- ISRCTNISRCTN73187232
- Date ISRCTN created16-mei-2005
- date ISRCTN requested12-apr-2005
- Date Registered NTR26-okt-2004
- Secondary IDs2003B261 
- Public TitlePrevention of cardiovascular disease and progression of renal failure in patients with chronic renal insufficiency: implementation of maximal endothelial protection with the aid of nurse practitioners. A randomized multi-center study.
- Scientific TitlePrevention of cardiovascular disease and progression of renal failure in patients with chronic renal insufficiency: implementation of maximal endothelial protection with the aid of nurse practitioners. A randomized multi-center study.
- ACRONYMMASTERPLAN (Multifactorial Approach and Superior Treatment Efficacy in
- hypothesisDoes intensive multifactorial coaching of patients with chronic renal insufficiency by nurse practitioners result in a reduction in cardiovascular events, cardiovascular mortality, all cause mortality and change in decline of renal function.
- Healt Condition(s) or Problem(s) studiedRenal insufficiency, Renal transplant, Cardiovascular disease
- Inclusion criteriaPatients are eligible for inclusion when they fulfill the following criteria: 1. The subject is at least 18 years old; 2. The subject is diagnosed with CKD with a creatinine clearance estimated by the Cockcroft-Gault equation between 20 and 70 ml/min; 3. The subject is able and willing to provide written informed consent.
- Exclusion criteriaAlso none of the exclusion criteria can be present. The following conditions are considered exclusion criteria: 1. A renal transplant less than a year before inclusion; 2. Acute renal failure or rapidly progressive glomerulonephritis established by the treating physician; 3. Any malignancy less than five years before inclusion other than basocellular or squamous cell carcinoma of the skin; 4. Participation in other clinical trials requiring the use of study medication.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 21-apr-2004
- planned closingdate21-apr-2009
- Target number of participants800
- InterventionsBloodpressure Standard : ACE-inhibitor or AII-antagonist (irbesartan) Target: < 130/85 mmHg Target: < 125/75 mmHg with proteďnuria > 1 g/dag. Proteďnuria Intensify antihypertensive therapy Target: < 0.5 g/dag. Dyslipidemia Standard: atorvastatine 10 mg Target : LDL< 2.59 mmol/l. Anemia Hb < 6.8 mmol/l: start darbepoietin alfa, treat iron deficiency Hyperhomocysteinemia Standard folicacid 5 mg/dag Thrombocyteaggregation Acetyl salicylic acid 80 mg/dag unless contra-indicated Diabetes mellitus Target : GlyHb < 7% Target: nuchtere glucose < 7.0 mmol/l Target: niet-nuchtere glucose < 10.0 mmol/l. Calcium-Phosphate Standard: alfacalcidol 0,25 µg/dag with clearance < 50 ml/min Target: Phosphate < 1.8 mmol/l and calcium 2.40- 2.60 mmol/l Target: PTH 1 – 3 x normal Lifestyle Standard: education about healthy nutrition by a qualified dietician Target: optimal bodyweight Standard: optimising physical activity to the level required by dutch guidelines Standard in case of smoking: stop smoking intervention.
- Primary outcome1. Assessment of cardiovascular morbidity (comprised of myocardial infarction, stroke and all vascular interventions, including amputation of an extremity due to vascular insufficiency); 2. Cardiovascular mortality; 3. All cause mortality.
- Secondary outcome1. Decline in renal function, this will be established by annual measurement of creatinine clearance by 24-hour urine measurements; 2. Quality of life, will be assessed using a validated questionnaire; 3. Markers of vascular damage: aortic pulse wave velocity, carotid intimal media thickness and the ankle-brachial index.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Arjan Zuilen, van
- CONTACT for SCIENTIFIC QUERIESDr. G. Ligtenberg
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Dutch Kidney Foundation (Nierstichting Nederland), Dutch Heart Foundation (Nederlandse Hartstichting), Amgen, Pfizer, Genzyme Corporation
- PublicationsN/A
- Brief summaryA 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. Eight hundred patients will be randomized to physician care or nurse practitioner support to detect a reduction of 50% in cardiovascular events, based on a power of 80%, a two-sided alpha of 0.05. For all patients the same set of guidelines and treatment goals 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 for five years after baseline. Primary endpoints are all cause mortality, cardiovascular morbidity and cardiovascular mortality. Secondary endpoints are decline of renal function, change in markers of vascular damage and quality of life.
- Main changes (audit trail)
- RECORD5-jul-2005 - 22-mei-2006


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