Study on Anti-inflammatory Effect of Anti-hypertensive Treatment in Patients With Small AAA's and Mild Hypertension

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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 pressure lowering is an important part of the treatment of patients with a dilated abdominal aorta who also have an elevated blood pressure. In the investigators study the investigators compare the anti-inflammatory effects of 2 different blood pressure lowering strategies. The investigators hypothesize that both strategies will decrease inflammation, however the investigators believe the total decrease of inflammation depends on the type of blood pressure lowering medication used.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VU University Medical Center
• Collaborator: Novartis
• Treatments: Amlodipine; Hydrochlorothiazide

Criteria

Inclusion Criteria:

1. Patients with a proven AAA of >30 mm and < 55 mm

2. Age between 18 and 75y (both inclusive)

3. Weight > 50 kg

4. Mild to moderate hypertension (defined as 130 < msSBP < 180 or 85< msDBP <110), at screening and/or baseline, without current antihypertensive medication.

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, acetylsalicylic acid 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, 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 < 45 mL/min/1.73 m2 MDRD

15. 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

16. 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.

17. 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.