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Completed

NCT Number: NCT01176032

ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Left Ventricle Hypertrophy Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Sanlúcar de Barrameda, Andalusia, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aliskiren

Drug

Aliskiren 300 mg film coated tablets

Other names: Rasilez

Losartan

Drug

Losartan 100 mg tablets

Amlodipine

Drug

Amlodipine 5mg was given to patients who did not achieve the required blood pressure (<140/90 mmHg) after 8 weeks (visit 3)of treatment at the maximum doses of study medication in addition to the study medication in order to reach the required BP. at visit 4 (week 18) the dose of amlodipine was increased to 10mg if the required level (<140/90 mmHg) was still not achieved.

Hydrochlorothiazide (HCTZ)

Drug

HCTZ 12.5mg was prescribed at visit 5 (week 26) if the required values (<140/90 mmHg) had not been reached.

Primary outcomes

  1. Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP)

    Time frame: Baseline, Week 36

    PICP is a measure of blood concentration of procollagen I carboxy-terminal propeptide (PICP), a peptide released from the myocardium when procollagen is converted to type I collagen. This biomarker exhibits good specificity and sensitivity for identifying myocardial fibrosis in hypertension.

Secondary outcomes

  1. Change From Baseline in Biomarkers in Heart Disease

    Time frame: Baseline, Week 36

    The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP)

  2. Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease

    Time frame: Baseline, Week 36

    The plasma level of biomarker parameter (aldosterone (Aldo)) used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI)

  3. 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

    Time frame: Baseline, Week 36

    Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule

  4. Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson)

    Time frame: Baseline, Week 36

    Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson)

  5. Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter

    Time frame: Baseline, Week 36

    Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter

  6. Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method)

    Time frame: Baseline, Week 36

    Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method)

  7. Change From Baseline in Reduction of Left Ventricular Mass Index (LVMI)

    Time frame: Baseline, Week 36

    Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI

  8. Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease.

    Time frame: Baseline, Week 36

    The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP)

  9. Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine

    Time frame: Baseline, Week 36

    The plasma level of biomarker parameter plasma aldosterone used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI).

  10. 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

    Time frame: Baseline, Week 36

    Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule

  11. Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine

    Time frame: Baseline, Week 36

    Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson)

  12. Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine

    Time frame: Baseline, Week 36

    Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter

  13. Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine

    Time frame: Baseline, Week 36

    Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method)

  14. Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine

    Time frame: Baseline, Week 36

    Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI

  15. Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP)

    Time frame: Baseline, Week 10,18,26,36

    The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values

  16. Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP)

    Time frame: Baseline, Week 10,18,26,36

    The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values

  17. Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate

    Time frame: Baseline, Week10,18,26,36

    Response rate was defined as the proportion of patients with a satisfactory systolic BP response (SBP < 140 mmHg or reduction of ≥ 10 mmHg compared to baseline) and a satisfactory diastolic BP response (DBP < 90 mmHg or reduction of ≥ 5 mmHg compared to baseline)

  18. 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

    Time frame: Week10,18,26,36

    The control rate was defined as the proportion of patients with SBP < 140 mmHg and DBP < 90 mmHg compared to baseline

  19. Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs

    Time frame: Baseline, Week 10,18,26

    The rate of use of first and second antihypertensive rescue drugs added was also assessed at all visits after week 2. The rescue drug at week 10 and 18 for those patients not achieving the required BP was amlodipine, Patients who did not achieve the required BP at week 26 were treated with hydrochlorothiazide

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: ALLMARK

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 5, 2010
Registry last updated
Jul 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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