Clinical trial NCT01176032: ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling
Official title: The "ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling (ALLMARK)" Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Left Ventricle Hypertrophy
Keywords: Aliskiren
hypertension
concentric LVH
LV remodeling
LVMI
biomarkers
PICP
CT-1
MMP-1
TIMP-1
AnxA5
Aldosterone
Essential hypertension with concentric left ventricle hypertrophy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-08-05
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

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

Primary outcomes:
measure: Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP)
timeFrame: Baseline, Week 36
Secondary outcomes:
measure: Change From Baseline in Biomarkers in Heart Disease
timeFrame: Baseline, Week 36
measure: Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease
timeFrame: Baseline, Week 36
measure: Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule
timeFrame: Baseline, Week 36
measure: Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson)
timeFrame: Baseline, Week 36
measure: Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter
timeFrame: Baseline, Week 36
measure: Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method)
timeFrame: Baseline, Week 36
measure: Change From Baseline in Reduction of Left Ventricular Mass Index (LVMI)
timeFrame: Baseline, Week 36
measure: Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease.
timeFrame: Baseline, Week 36
measure: Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine
timeFrame: Baseline, Week 36
measure: Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine
timeFrame: Baseline, Week 36
measure: Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine
timeFrame: Baseline, Week 36
measure: Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine
timeFrame: Baseline, Week 36
measure: Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine
timeFrame: Baseline, Week 36
measure: Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine
timeFrame: Baseline, Week 36
measure: Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP)
timeFrame: Baseline, Week 10,18,26,36
measure: Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP)
timeFrame: Baseline, Week 10,18,26,36
measure: Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate
timeFrame: Baseline, Week10,18,26,36
measure: Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline
timeFrame: Week10,18,26,36
measure: Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs
timeFrame: Baseline, Week 10,18,26
Other outcomes:
Locations:
city: Sanlúcar de Barrameda
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Utrera
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Burgos
country: Spain
facility: Novartis Investigative Site
state: Castilla y Leon
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Girona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: L'Hospitalet de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Santa Coloma de Gramanet
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Alicante
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Torrevieja (Alicante)
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Santiago de Compostela
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Galdakano
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: Bilbao
country: Spain
facility: Novartis Investigative Site
state: País Vasco
city: Vitoria
country: Spain
facility: Novartis Investigative Site
state: País Vasco
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Santander
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References: