Dual RAS-blockade by ACE-inhibition and AT1 receptor blockade, role of the ACE I/D genotype and low sodium diet in non-diabetic proteinuric patients.
- Conditions
- non-diabetic proteinuria
- Registration Number
- NL-OMON23057
- Brief Summary
Moderate dietary sodium restriction added to angiotensin converting enzyme inhibition compared with dual blockade in lowering proteinuria and blood pressure: randomised controlled trial.<br> Slagman MC, Waanders F, Hemmelder MH, Woittiez AJ, Janssen WM, Lambers Heerspink HJ, Navis G, Laverman GD; HOlland NEphrology STudy Group. BMJ. 2011 Jul 26;343:d4366. doi: 10.1136/bmj.d4366. <br><br> PMID nummer van de plublicatie: 21791491
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 56
1. Age older than 18 year;
2. Chronic non-diabetic renal disease, as established by history, urine analysis, serum biochemistry tests and/or renal biopsy;
3. Creatinine clearance > 30 ml/min/1.73 m;
4. Residual proteinuria > 1 g/24h.
1. Failure to comply with the above inclusion criteria;
2. Diabetes mellitus;
3. Any contra-indication against the use of ACE inhibitors or AT1 receptor blockers;
4. A history of myocardial infarction, unstable angina, coronary by-pass or CVA during the past 6 months;
5. Heart failure NYHA class III-IV;
6. High rate of renal function loss (decline in creatinine clearance > 6 ml/min/1.73m2 during the previous year);
7. Need for treatment with corticosteroids, NSAID’s or immunosuppressive drugs;
8. Proteinuria > 10 g/24h and hypoalbuminaemia < 28 g/L;
9. Renovascular hypertension, malignant hypertension (diastolic blood pressure > 100 mmHg);
10. Serum potassium > 6 mmol/L.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint will be reduction of proteinuria and blood pressure expressed as percentage change from baseline and analysed with each patient as his or her own control.
- Secondary Outcome Measures
Name Time Method 1. Serum creatinine;<br>2. Circulating RAS parameters;<br>3. Lipid profile;<br>4. Adiponectin.