systemische en glomerulaire hypertensie elevated blood pressure in the kidney glomerular hypertension
Conditions
Interventions
Treatment period 1: aliskiren 1dd 300 mg and placebo ramipril (double-dummy
design)
Treatment periode 2: ramipril 1dd 10 mg and placebo aliskiren (double-dummy
design)
Treatment period is randomise
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Male caucasian patients - Age >=18 and =27 and =140 or >=90 mmHg, respectively) - Normal renal function (creatinine clearance >90 ml/min/1.73m2) - Normo- or microalbuminuria (albuminuria
Exclusion criteria
Exclusion criteria: - Inability to meet inclusion criteria - Previously treated (within 3 months prior to start of study) with aliskiren or ramipril. - Cardiovascular disease (myocardial infarction, angina pectoris, percutanous transluminal coronary angioplasty, coronary artery bypass grafting, stroke, heart failure (NYHA I-IV), Diabetes Mellitus - Active malignancy - Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following: - History of active inflammatory bowel disease within the last six months; - Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; - Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months; - Pancreatic injury or pancreatitis within the last six months; - Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at inclusion visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt; - Evidence of urinary obstruction of difficulty in voiding at inclusion - History of severe hypersensitivity or contraindications to ramipril or aliskiren - Hypersensitivity to 125I-iothalamate or 131I-hippuran - History of angioedema - History of autonomic dysfunction (e.g. history of fainting or clinically significant orthostatic hypotension) - Participation in any clinical investigation within 3 months prior to start of the study - Donation or loss of 400 ml or more of blood within 3 months prior to initial dosing - History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening. - History of noncompliance to medical regimens or unwillingness to comply with the study protocol. - Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Renal hemodynamics (GFR, ERPF, FF) - Blood pressure | — |
Secondary
| Measure | Time frame |
|---|---|
| - Volume status (extracellular fluid volume/ECV) - RAAS parameters (plasma renin activity, plasma renin concentration, angiotensin II, aldosteron) - Urine en derum 'kidney injury markers', zoals, maar niet uitsluitend, TGFß, KIM-1, NGAL en NAG. | — |
Countries
Netherlands
Outcome results
None listed