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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.

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25012
Enrollment
800
Registered
2004-10-26
Start date
2004-04-21
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Bloodpressure Standard : ACE-inhibitor or AII-antagonist (irbesartan) Target: 1 g/dag. Proteïnuria Intensify antihypertensive therapy Target: < 0.5 g/dag. Dyslipidemia Standard: atorvastatine 10 mg

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients 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 criteria

Exclusion criteria: Also 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactArjan Zuilen, van

University Medical Center Utrecht (UMCU), Department of Nephrology, room F03-226 P.O. Box 85500

a.vanzuilen@azu.nl+31 (0)30 2509768

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)