|
Welcome
|
|
23 May 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ ...Back to search results ] | [ Print-friendly version ] |
| Multifactorial Approach and Superior Treatment Efficacy in Renal Patients with the Aid of Nurse practitioners |
| ISRCTN | ISRCTN73187232 |
| ClinicalTrials.gov identifier | |
| Public title | Multifactorial Approach and Superior Treatment Efficacy in Renal Patients with the Aid of Nurse practitioners |
| Scientific title | 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 randomised multi-centre study |
| Acronym | MASTERPLAN |
| Serial number at source | 2003B261; NTR22 |
| Study hypothesis | Does 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? |
| Lay summary | |
| Ethics approval | Ethics approval received from the local medical ethics committee |
| Study design | Multicentre randomised active controlled parallel group trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Chronic renal insufficiency, renal transplant, cardiovascular disease |
| Participants - inclusion criteria |
1. The subject is at least 18 years old
2. The subject is diagnosed with chronic kidney disease (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 |
| Participants - exclusion criteria |
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 |
| Anticipated start date | 21/04/2004 |
| Anticipated end date | 21/04/2009 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 800 |
| Interventions |
After the baseline evaluation, the patient will be randomised to either nurse practitioner care or physician care. To all patients the same set of guidelines and treatment goals, shown below, apply. Both patients and physicians are provided with information about the beneficial effects of multifactorial risk factor management regardless of treatment allocation. In the intervention group nurse practitioners, supervised by a qualified nephrologist, will actively pursue lifestyle intervention (physical exercise, nutritional counseling, weight reduction and smoking cessation), the use of specified cardioprotective medication and the implementation of current guidelines. Physician care comprises 'usual care' and conforms to the guidelines below.
Targets and guidelines: 1. Blood pressure: Standard: ACE-inhibitor or AII-antagonist (irbesartan) Target: less than 130/85 mmHg (less than 125/75 mmHg with proteinuria greater than 1 g/day) 2. Proteinuria intensify anti-hypertensive therapy Target: less than 0.5 g/dag 3. Dyslipidaemia: Standard: atorvastatine 10 mg Target: Low Density Lipoprotein (LDL) cholesterol less than 2.59 mmol/l 4. Anaema Hb less than 6.8 mmol/l: Start darbepoietin alfa, treat iron deficiency 5. Hyperhomocysteinemia: Standard folic acid 5 mg/dag 6. Thrombocyte aggregation: Acetylsalicylic acid 80 mg/dag unless contra-indicated 7. Diabetes mellitus: Target: HbA1c less than 7% (preprandial glucose less than 7.0 mmol/l, postprandial glucose less than 10.0 mmol/l) 8. Calcium-Phosphate: Standard: alfacalcidol 0.25 µg/dag with clearance less than 50 ml/min Target: Phosphate less than 1.8 mmol/l and calcium 2.40 - 2.60 mmol/l (parathyroid hormone (PTH) 1 - 3 x normal) 9. 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 outcome measure(s) |
1. 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 outcome measure(s) |
1. 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 |
| Sources of funding |
1. Dutch Kidney Foundation (Nierstichting Nederland) (Netherlands) (ref: pv-01)
2. Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands) (ref: 2003B261) Unrestricted grants from: 1. Amgen (Netherlands) 2. Pfizer (Netherlands) 3. Genzyme (Netherlands) |
| Trial website | |
| Publications |
1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16573836
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18587712 3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20382963 |
| Contact name | Dr Arjan van Zuilen |
| Address |
Department of Nephrology
University Medical Center Utrecht F03-226 P.O. Box 85500 |
| City/town | Utrecht |
| Zip/Postcode | 3508 GA |
| Country | Netherlands |
| Tel | +31 (0)30 250 97 68 |
| Fax | +31 (0)30 254 34 92 |
| a.vanzuilen@azu.nl | |
| Sponsor | University Medical Centre Utrecht (UMCU) (Netherlands) |
| Address | P.O. Box 85500 |
| City/town | Utrecht |
| Zip/Postcode | 3508 GA |
| Country | Netherlands |
| Sponsor website: | http://www.umcutrecht.nl/zorg/ |
| Date applied | 16/05/2005 |
| Last edited | 13/04/2010 |
| Date ISRCTN assigned | 16/05/2005 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|