ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling (ALLMARK)
Hypertension, Left Ventricle Hypertrophy
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Aliskiren, hypertension, concentric LVH, LV remodeling, LVMI, biomarkers, PICP, CT-1, MMP-1, TIMP-1, AnxA5, Aldosterone, Essential hypertension with concentric left ventricle hypertrophy
Eligibility Criteria
Inclusion Criteria:
- Patient with hypertension
- Confirmed concentric left ventricular hypertrophy:
- LVMI > 49.2 g/m2.7 for men and >46.7 g/m2.7 for women
- Relative wall thickness > 0.42
Exclusion Criteria:
- Sever or secondary HTN
- LV ejection fraction of <40%
- Patient with compelling indication to ACEIs or ARBs or BB
- History of myocardial infarction, coronary artery bypass surgery, PTC intervention, TIA or stroke within 6 months of study entry
- History of collagenopathies, osteopathy
- eGFR <30 ml/min/1,73 m2, serum potassium ≥5,2 mEq/L
- Morbid obesity (BMI ≥ 42 kg/m2
- Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Aliskiren
Lostaran
Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks. In addition to the study medication, amlodipine 5mg was given to patients who did not achieve the required blood pressure (<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication. At week 18 the dose of amlodipine was increased to 10mg if the required level (<140/90 mmHg) was still not achieved. HCTZ 12.5mg was prescribed at week 26 if the required values (<140/90 mmHg) had not been reached.
Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks. In addition to the study medication, amlodipine 5mg was given to patients who did not achieve the required blood pressure (<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication. At week 18 the dose of amlodipine was increased to 10mg if the required level (<140/90 mmHg) was still not achieved. HCTZ 12.5mg was prescribed at week 26 if the required values (<140/90 mmHg) had not been reached.