An exploratory open-label PET-observer-blinded pilot study to evaluate the effect of 3 and 12 months treatment with Aliskeren-based versus amlodipin-based antihypertensive treatment in patients with a small abdominal aortic aneurysm and mild to moderate hypertension on aneurysmal FDG-uptake as measured with FDG PET

An exploratory open-label PET-observer-blinded pilot study to evaluate the effect of 3 and 12 months treatment with Aliskeren-based versus amlodipin-based antihypertensive treatment in patients with a small abdominal aortic aneurysm and mild to moderate hypertension on aneurysmal FDG-uptake as measured with FDG PET - Aliskiren_AAA_PET

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35808

Enrollment

Registered

2011-05-10

Start date

2011-12-08

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dilatation of the abdominal aorta

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients with a proven AAA of >30 mm and 50 kg 4. Mild to moderate hypertension (defined as 130

Exclusion criteria

Exclusion criteria: 1. Patients without an AAA, or with an AAA * 55 mm, or * 30 mm 2. Patients with an AAA who are eligible for surgical repair for any reason 3. Diabetes mellitus 4. 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 5. Severe hypertension (msSBP *180 mmHg and/or msDBP *110 mmHg) at screening and/or baseline 6. Pregnant or nursing (lactating) women 7. Known or suspected contraindications, including history of allergy or hypersensitivity (such as angioedema) to DRIs, CCBs, ACEIs, statins or diuretics in general (for example, to aliskiren / amlodipine / hydrochlorothiazide / statins) 8. Concomitant drugs that are strong inhibitors of CYP3A4 or P-glycoprotein inhibitors (ketoconazole, itraconazole, nefazodone, rolandeomycin, clarithromycin, ritonavir, nelfinavir, cyclosporine, verapamil, quinidine) 9. Previous or current diagnosis of heart failure (NYHA Class II-IV) 10. Second or third degree heart block without a pacemaker, or potentially life-threatening arrhythmia during the 12 months prior to screening 11. Clinically symptomatic valvular heart disease at screening visit 12. A past medical history of clinically significant ECG abnormalities 13. Confirmed serum potassium *5.3 mEq/L (mmol/L) at screening or baseline. 14. Impaired renal function, defined as eGFR

Design outcomes

Primary

Measure	Time frame
- Change from baseline in aneurismal FDG-uptake as measured with PET-CT after 3 and 12 months	—

Secondary

Measure	Time frame
- Variation of aneurismal FDG-uptake as measured with PET-CT after 3 and 12 months - Change from baseline in aneurismal diameter after 12 months - Change from baseline in FDG-uptake in other large blood vessels after 3 and 12 months	—

Countries

Netherlands

Outcome results