Evaluation of Clinical Effectiveness in Real-World Clinical Practice, as Well as the Safety and Adherence to Therapy With a Fixed-Dose Combination of Amlodipine and Valsartan
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 216
- 试验地点
- 18
- 主要终点
- Proportion of participants achieving target blood pressure at 12 weeks
研究概览
简要总结
The goal of this observational study is to evaluate the effectiveness, safety, and treatment adherence of a fixed-dose combination of amlodipine and valsartan in adults with grade 2-3 hypertension in real-world clinical practice in Kazakhstan. The study will include patients who have already been prescribed the fixed-dose combination of amlodipine and valsartan (Agvistat®) by their treating physician as part of routine medical care, independently of their participation in the study.
The main questions it aims to answer are:
What proportion of participants achieve the target blood pressure after 12 weeks of treatment with the fixed-dose combination of amlodipine and valsartan? How well do participants adhere to treatment, and what patient characteristics are associated with treatment adherence? What changes occur in blood pressure, heart rate, quality of life, and selected laboratory measures during the 12-week observation period? What adverse events occur during treatment?
Participants will:
Have their clinical and demographic information and data from routine medical care recorded during the study.
Have blood pressure, heart rate, and other relevant clinical data assessed during the 12-week observation period.
Complete questionnaires assessing treatment adherence and quality of life. Participate in follow-up visits at 4, 8, and 12 weeks; the 4- and 8-week visits will be conducted remotely, while the enrollment and 12-week visits will be conducted at the study site.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants aged ≥18 years at the time of enrollment.
- •Signed and dated written informed consent in accordance with ICH GCP and applicable local legislation before enrollment in the study.
- •Women of childbearing potential must use an adequate method of contraception throughout the study.
- •Documented diagnosis of grade 2-3 hypertension according to current clinical guidelines for hypertension, defined as systolic blood pressure (SBP) ≥140 mmHg and/or diastolic blood pressure (DBP) ≥90 mmHg measured at two different visits.
- •Treatment with a fixed-dose combination of amlodipine and valsartan (Agvistat®) prescribed by the treating physician as part of standard clinical practice before enrollment, independently of participation in this study.
- •Medical history indicating failure to achieve target blood pressure while receiving a free combination of antihypertensive drugs.
排除标准
- •Participation in any randomized controlled trial within 3 months before enrollment in this study or during participation in this study.
- •Atrial fibrillation; severe chronic heart failure (NYHA functional class III-IV or left ventricular ejection fraction ≤40% by echocardiography); or acute coronary syndrome or acute cerebrovascular event within the previous year.
- •Secondary hypertension.
- •Contraindications or conditions requiring caution listed in the prescribing information for the fixed-dose combination of amlodipine and valsartan, including: hypersensitivity to the active substances, other dihydropyridine derivatives, or any excipients; severe hepatic impairment, biliary cirrhosis, or cholestasis; concomitant use of aliskiren-containing medicinal products in patients with diabetes mellitus or renal impairment (eGFR <60 mL/min/1.73 m²); second or third trimester of pregnancy; severe hypotension; shock, including cardiogenic shock; left ventricular outflow tract obstruction, including hypertrophic obstructive cardiomyopathy or severe aortic stenosis; and hemodynamically unstable heart failure following acute myocardial infarction.
研究组 & 干预措施
Amlodipine/valsartan-treated cohort
Adults with grade 2-3 hypertension who have been prescribed a fixed-dose combination of amlodipine and valsartan (Agvistat®) by their treating physician as part of routine clinical practice, independently of participation in the study. Participants are observed for up to 12 weeks to assess treatment effectiveness, adherence, safety, blood pressure control, and quality of life.
干预措施: Amlodipine / Valsartan (Drug)
结局指标
主要结局
Proportion of participants achieving target blood pressure at 12 weeks
时间窗: 12 weeks
Proportion of participants who achieve the target blood pressure after 12 weeks of therapy: \<140/90 mmHg for the general population or \<130/80 mmHg for participants at high cardiovascular risk and participants younger than 60 years.
次要结局
- Association between treatment adherence and clinical and demographic characteristics(12 weeks)
- Change in heart rate from baseline(12 weeks)
- Change in alanine aminotransferase (ALT) from baseline(12 weeks)
- Change in aspartate aminotransferase (AST) from baseline(12 weeks)
- Change in serum creatinine from baseline(12 weeks)
- Change in blood glucose from baseline(12 weeks)
- Change in low-density lipoprotein cholesterol from baseline(12 weeks)
- Change in body mass index from baseline(12 weeks)
- Change in EQ-5D quality of life score(12 weeks)
- Association of clinical and demographic factors with achievement of target blood pressure(12 weeks)
- Patient satisfaction with treatment(12 week)
- Frequency and characteristics of adverse drug reactions(12 weeks)