No registrations found.
ID
Source
Brief title
Health condition
essential hypertension, glomerular hypertension, overweight, obesity
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Renal hemodynamics (GFR, ERPF, FF);
2. Blood pressure.
Secondary outcome
1. Volume status (extracellular fluid volume - ECFV);
2. RAAS parameters (plasma renin activity, plasma renin concentration, angiotensin II, aldosteron);
3. Urinary and serum kidney injury markers.
Background summary
N/A
Study objective
Aliskiren can decrease glomerular pressure, in respect to ramipril, in patients with essential hypertension and overweight/obesity, independent from blood pressure.
Study design
After a wash-out period of 6 weeks, patients are randomly assigned to either a 6-week treatment period with aliskiren or a 6-week treatment period with ramipril in a cross-over design. Between both treatment periods an 8-week wash-out period is present. Renal hemodynamics are measured at start and end of both 6-week treatment periods.
Intervention
1. Aliskiren 1dd 300 mg p.o.;
2. Ramipril 1dd 10 mg p.o..
Inclusion criteria
1. Male caucasian patients;
2. Age >18 and <70 years;
3. Overweight or obese (BMI >27 and <35 kg/m2);
4. Essential hypertension according to WHO-criteria (systolic and diastolic bloodpressure >140 or <90 mmHg, respectively);
5. Normal renal function (creatinine clearance >90 ml/min/1.73m2);
6. Normo- or microalbuminuria (albuminuria <300mg/day);
7. Written informed consent.
Exclusion criteria
1. Inability to meet inclusion criteria;
2. Previously treated (within 3 months prior to start of study) with aliskiren or ramipril;
3. Cardiovascular disease (myocardial infarction, angina pectoris, percutanous transluminal coronary angioplasty, coronary artery bypass grafting, stroke, heart failure (NYHA I-IV), Diabetes Mellitus;
4. Active malignancy;
5. 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:
A. History of active inflammatory bowel disease within the last six months;
B. Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
C. Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months;
D. Pancreatic injury or pancreatitis within the last six months;
E. Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at inclusion, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt;
F. Evidence of urinary obstruction of difficulty in voiding at inclusion.
6. History of severe hypersensitivity or contraindications to ramipril or aliskiren;
7. Hypersensitivity to 125I-iothalamate or 131I-hippuran;
8. History of angioedema;
9. History of autonomic dysfunction (e.g. history of fainting or clinically significant orthostatic hypotension);
10. Participation in any clinical investigation within 3 months prior to start of the study;
11. Donation or loss of 400 ml or more of blood within 3 months prior to initial dosing;
12. 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;
13. History of noncompliance to medical regimens or unwillingness to comply with the study protocol;
14. 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
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL2424 |
NTR-old | NTR2532 |
CCMO | NL33146.042.10 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON34045 |