The effectiveness of intensive treatment on sympathetic hyperactivity. A randomized, cross-over trial in patients with chronic kidney disease and hypertension
Phase 3
Withdrawn
- Conditions
- Hypertensiechronic kidney diseasesChronic renal diseases10029149
- Registration Number
- NL-OMON31888
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Patients with stable chronic kidney disease and hypertension: i.e. using antihypertensive drugs and/or blood pressure >145/90mmHg when off medication.
Exclusion Criteria
Patients with diabetes mellitus and patients on renal replacement therapy are excluded. In addition, patients with severe liver insufficiency, biliary cirrhosis and cholestasis, use of calcium antagonists en beta-blockers, pregnant patients and patients in lactation are excluded as Valsartan is contra-indicated for these patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint/outcome<br /><br><br /><br>- Primary endpoint: the effect of increasing dosage of valsartan on MSNA<br /><br><br /><br>- Primary expected outcome: further decrease in MSNA as compared to the MSNA<br /><br>during standard dosage </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoint/outcome<br /><br><br /><br><br /><br>1. Secondary endpoint: assessment of normalization of MSNA after application of<br /><br>higher than usual dosage of valsartan<br /><br>- Secondary expected outcome: normalization of MSNA after application of higher<br /><br>than usual dosage of valsartan<br /><br><br /><br><br /><br>2. Effect of higher than usual dosage of valsartan on blood pressure<br /><br><br /><br>- Secondary outcome: higher than usual dosage of valsartan will not have a<br /><br>further effect on blood pressure</p><br>