Renal hemodynamic effects of aliskiren (rasilez) in comparison to ramipril (tritrace) in patients with overweight/obesity and hypertensio

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

- Male caucasian patients
- Age >=18 and <=70 years
- Overweight or obese (BMI >=27 and <=35 kg/m2)
- Essential hypertension according to WHO-criteria (systolic and diastolic blood pressure >=140 or
>=90 mmHg, respectively)
- Normal renal function (creatinine clearance >90 ml/min/1.73m2)
- Normo- or microalbuminuria (albuminuria <=300mg/day)
- Written informed consent

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Renal hemodynamics (GFR, ERPF, FF)<br /><br>- Blood pressure</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Volume status (extracellular fluid volume/ECV)<br /><br>- RAAS parameters (plasma renin activity, plasma renin concentration,<br /><br>angiotensin II, aldosteron)<br /><br>- Urine en derum 'kidney injury markers', zoals, maar niet uitsluitend, TGFß,<br /><br>KIM-1, NGAL en NAG.</p><br>