ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling (ALLMARK)

Novartis

Status and phase: Completed; Phase 4

Conditions: Left Ventricle Hypertrophy; Hypertension

Treatments: Drug: Amlodipine; Drug: Hydrochlorothiazide (HCTZ); Drug: Losartan; Drug: Aliskiren

Study type: Interventional

Funder types: Industry

Identifiers

NCT01176032

CSPP100AES02

2009-016735-36 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to assess efficacy of aliskiren for reducing circulating levels of biomarkers of left ventricular (LV) remodeling associated with LV hypertrophy (LVH) in hypertensive patients.

Full description

Blood pressure was measured 10 weeks after starting treatment (visit 3). All patients who did not achieve the required blood pressure (<140/90 mmHg) after 8 weeks of treatment at the maximum doses of study medication were given 5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg).

The patient's blood pressure was assessed at visit 4 (week 18) and if it was still not at the required level (<140/90 mmHg), the dose of amlodipine was increased to 10 mg.

Blood pressure was again assessed at visit 5 (week 26) and if the required values had not been reached (<140/90 mmHg), a 12.5 mg dose of hydrochlorothiazide (HCTZ) was prescribed

Enrollment: 74 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Aliskiren

Experimental group

Description:

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.

Treatment:

Drug: Hydrochlorothiazide (HCTZ)

Drug: Aliskiren

Drug: Amlodipine

Lostaran

Active Comparator group

Description:

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.

Treatment:

Drug: Hydrochlorothiazide (HCTZ)

Drug: Losartan

Drug: Amlodipine