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Renal hemodynamic effects of aliskiren in comparison to ramipril.


- candidate number8485
- NTR NumberNTR2532
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-sep-2010
- Secondary IDsNL33146.042.10 / 2010.228 ; CCMO / METC UMCG
- Public TitleRenal hemodynamic effects of aliskiren in comparison to ramipril.
- Scientific TitleRenal hemodynamic effects of aliskiren (rasilez) in comparison to ramipril (tritrace) in patients with overweight/obesity and hypertension.
- ACRONYMrenal HEALTH-STudY
- hypothesisAliskiren can decrease glomerular pressure, in respect to ramipril, in patients with essential hypertension and overweight/obesity, independent from blood pressure.
- Healt Condition(s) or Problem(s) studiedOverweight, Obesity, Essential hypertension, Glomerular hypertension
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2011
- planned closingdate1-jan-2012
- Target number of participants16
- Interventions1. Aliskiren 1dd 300 mg p.o.;
2. Ramipril 1dd 10 mg p.o..
- Primary outcome1. Renal hemodynamics (GFR, ERPF, FF);
2. Blood pressure.
- Secondary outcome1. 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.
- TimepointsAfter 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.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. G.D. Laverman
- CONTACT for SCIENTIFIC QUERIESDr. G.D. Laverman
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Novartis
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD22-sep-2010 - 16-dec-2012


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