Prevention of cardiovascular disease and progression of renal failure inpatients with chronic renal insufficiency: implementation of maximalendothelial protection with the aid of nurse practitioners. A randomizedmulti-center study.
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 800
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Assessment of cardiovascular morbidity (comprised of myocardial infarction, stroke and all vascular interventions, including amputation of an extremity due to vascular insufficiency);<br>2. Cardiovascular mortality;<br>3. All cause mortality. <br>
- Secondary Outcome Measures
Name Time Method 1. Decline in renal function, this will be established by annual measurement of creatinine clearance by 24-hour urine measurements;<br>2. Quality of life, will be assessed using a validated questionnaire;<br>3. Markers of vascular damage: aortic pulse wave velocity, carotid intimal media thickness and the ankle-brachial index.