Status:
TERMINATED
Study on Anti-inflammatory Effect of Anti-hypertensive Treatment in Patients With Small AAA's and Mild Hypertension
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
Novartis
Conditions:
Hypertension
Abdominal Aortic Aneurysm
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Inflammation of the blood vessel plays an important role in the development and growth of a dilated abdominal aorta. An elevated blood pressure leads to an increase in inflammation, therefore blood pr...
Detailed Description
Standard therapy of small AAAs currently consists of "watchful waiting" strategy with aggressive blood pressure control "Watchful waiting" includes an Ultrasound (more recently CT or MRI scan) every 1...
Eligibility Criteria
Inclusion
- Patients with a proven AAA of \>30 mm and \< 55 mm
- Age between 18 and 75y (both inclusive)
- Weight \> 50 kg
- Mild to moderate hypertension (defined as 130 \< msSBP \< 180 or 85\< msDBP \<110), at screening and/or baseline, without current antihypertensive medication.
Exclusion
- Patients without an AAA, or with an AAA ≥ 55 mm, or ≤ 30 mm
- Patients with an AAA who are eligible for surgical repair for any reason
- Diabetes mellitus
- Inability of the subjects to switch from all prior antihypertensive medications safely as required by the protocol and need for drugs other than study drugs at the time of baseline
- Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg) at screening and/or baseline
- Pregnant or nursing (lactating) women
- Known or suspected contraindications, including history of allergy or hypersensitivity (such as angioedema) to DRIs, CCBs, ACEIs, statins, acetylsalicylic acid or diuretics in general (for example, to aliskiren / amlodipine / hydrochlorothiazide / statins)
- Concomitant drugs that are strong inhibitors of CYP3A4 or P-glycoprotein inhibitors (ketoconazole, itraconazole, nefazodone, clarithromycin, ritonavir, nelfinavir, cyclosporine, verapamil, quinidine)
- Previous or current diagnosis of heart failure (NYHA Class II-IV)
- Second or third degree heart block without a pacemaker, or potentially life-threatening arrhythmia during the 12 months prior to screening
- Clinically symptomatic valvular heart disease at screening visit
- A past medical history of clinically significant ECG abnormalities
- Confirmed serum potassium ≥5.3 mEq/L (mmol/L) at screening or baseline.
- Impaired renal function, defined as eGFR \< 45 mL/min/1.73 m2 MDRD
- Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulation
- Participation in any clinical investigation within four (4) weeks prior to first dose or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- Patients who have undergone prior radionuclide treatment or examinations or X-ray examinations with a cumulative radiation exposure, which added to the radiation exposure of the current study, would exceed local limits.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01425242
Start Date
September 1 2011
End Date
December 1 2013
Last Update
December 9 2014
Active Locations (1)
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1
VU University Medical Center
Amsterdam, Netherlands, 1007 MB