Phase 4 N=74 Randomized Treatment

ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling

Hypertension · Left Ventricle Hypertrophy

Bottom Line

View on ClinicalTrials.gov: NCT01176032 ↗

Enrolled (actual)

Serious AEs

2.7%

Results posted

Jul 2014

Primary outcome: Primary: Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP) — -5.22; -4.25 ug/l

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Aliskiren (Drug); Losartan (Drug); Amlodipine (Drug); Hydrochlorothiazide (HCTZ) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Apr 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP)	-5.22; -4.25	—
SECONDARY Change From Baseline in Biomarkers in Heart Disease	-169.15; -128.23; 5.93; 5.51; -0.70; 9.15	—
SECONDARY Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease	-1.81; -7.90	—
SECONDARY 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	2.30; 0.54; -0.92; 0.64	—
SECONDARY Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson)	0.00; 0.01; 0.02; 0.00	—
SECONDARY Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter	-0.13; -0.22	—
SECONDARY Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method)	-0.55; -2.27	—
SECONDARY Change From Baseline in Reduction of Left Ventricular Mass Index (LVMI)	-8.05; -7.96	—
SECONDARY Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease.	-289.18; -63.23; 156.89; -345.47; -1.24; -0.74	—
SECONDARY Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine	2.81; -5.89; -3.12; -11.55	—
SECONDARY 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	6.60; -2.00; 5.01; -2.98; -2.93; 1.09	—
SECONDARY Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine	0.00; -0.00; -0.00; 0.01; 0.05; -0.01	—
SECONDARY Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine	-0.18; -0.07; -0.19; -0.24	—
SECONDARY Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine	-8.88; 7.78; -7.42; 1.30	—
SECONDARY Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine	-5.68; -10.26; -3.59; -11.46	—
SECONDARY Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP)	-5.56; -4.03; -9.77; -8.44; -12.69; -10.40	—
SECONDARY Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP)	-1.77; -3.15; -5.34; -7.07; -5.34; -6.94	—
SECONDARY Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate	16; 15; 24; 21; 24; 27	—
SECONDARY 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	15; 13; 20; 19; 22; 23	—
SECONDARY Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs	11; 15; 2; 9; 2; 4	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01176032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.