Renal Hemodynamic Effects of ALiskiren (rasilez) in comparison to ramipril (Tritrace) in patients with overweigHt/obeSiTy and UntreateD hYpertension: The renal HEALTH-STUDY - The renal HEALTH-STUDY

• Conditions: Glomerular hypertension; MedDRA version: 12.1Level: LLTClassification code 10020772Term: Hypertension

• Registration Number: EUCTR2010-021987-13-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• 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/1.73mm2)
- Normo- or microalbuminuria (albuminuria =300mg/day)
- Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 8 weeks prior to initial dosing or
longer if required by local regulation.
- 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: N.A.;Primary end point(s): - Renal hemodynamics (GFR, ERPF, FF)<br>- Blood pressure<br>;Main Objective: To determine the effects of aliskiren, as compared to ramipril, on renal hemodynamics in overweight/obese and hypertensive patients.