The "ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling (ALLMARK)" Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Aliskiren
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.
干预措施: Aliskiren (Drug)
Aliskiren
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.
干预措施: Amlodipine (Drug)
Aliskiren
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.
干预措施: Hydrochlorothiazide (HCTZ) (Drug)
Lostaran
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.
干预措施: Losartan (Drug)
Lostaran
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.
干预措施: Amlodipine (Drug)
Lostaran
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.
干预措施: Hydrochlorothiazide (HCTZ) (Drug)
结局指标
主要结局
Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP)
时间窗: 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.
次要结局
- Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease(Baseline, Week 36)
- Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter(Baseline, Week 36)
- Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine(Baseline, Week 36)
- 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(Baseline, Week 36)
- 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(Baseline, Week 36)
- Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method)(Baseline, Week 36)
- Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease.(Baseline, Week 36)
- Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine(Baseline, Week 36)
- Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine(Baseline, Week 36)
- Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP)(Baseline, Week 10,18,26,36)
- Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs(Baseline, Week 10,18,26)
- Change From Baseline in Biomarkers in Heart Disease(Baseline, Week 36)
- Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson)(Baseline, Week 36)
- Change From Baseline in Reduction of Left Ventricular Mass Index (LVMI)(Baseline, Week 36)
- Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine(Baseline, Week 36)
- Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine(Baseline, Week 36)
- Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP)(Baseline, Week 10,18,26,36)
- Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate(Baseline, Week10,18,26,36)
- 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(Week10,18,26,36)