A Prospective, Non-interventional, Observational Study To Describe the Effectiveness of Trandolapril (Mavik®) in the Management of Patients Requiring Angiotensin Converting Enzyme Inhibitor Treatment (In-MAU-tion)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 7,993
- 试验地点
- 568
- 主要终点
- Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 3 Months
研究概览
简要总结
The in-MAU-tion study is conducted to determine the percentage of hypertensive participants with or without diabetes reaching CHEP (Canadian Hypertension Education Program) defined blood pressure targets. Additionally, the study assesses change in renal function (microalbuminuria, estimated glomerular filtration rate) in hypertensive participants treated with trandolapril (Mavik®) and examines patient satisfaction with trandolapril (Mavik®) therapy.
详细描述
There are no interventional implications in this study. The study runs under consideration of Canadian Hypertension Education Program guidelines and as per standard practice of care. Data collection is recorded on the appropriate case report forms. The data collected consist of: patient demographics (gender, race, age, weight), blood pressure readings, heart rate, coexisting comorbidities, concomitant chronic medications (generic name and dosage), indication and dose for trandolapril (Mavik®) and patient compliance. Laboratory values (microalbuminuria, estimated glomerular filtration rate) are only collected if the data are available for each patient. For baseline values (study Day 0), any laboratory value recorded within the past year prior to the baseline visit (Visit 1) is recorded, if the value is available. As per Canadian Hypertension Education Program recommendations and as a support and educational measure, patients are provided with (1) educational tools (nutrition guidebooks) and (2) home blood pressure monitoring devices. As per research and development guidelines, blood pressure devices were retrieved at the end of the study. Approximately 8,000 hypertensive participants were enrolled in the study at up to 700 sites across Canada. Sample size estimations were based on the assumption that 67.2% of non-diabetic hypertensive participants (assumed to make up to 69% of the eligible participant population) would reach a blood pressure target of <140/90mm Hg, while 22% of diabetes participants (31% of the eligible population) would meet a blood pressure target of <130/80 mm Hg with trandolapril (Mavik®) therapy.
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
- •Adults capable of providing consent and who have uncontrolled hypertension
- •Participants were either treatment-naïve or had uncontrolled hypertension on their existing antihypertensive medication.
排除标准
- •Participants were excluded from participation in the study if they had been taking trandolapril (Mavik®), alone or in combination, for more than 1 month prior to enrollment.
结局指标
主要结局
Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 3 Months
时间窗: 3 months
Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<140/90 mm Hg for non-diabetic participants, and SBP/DBP \<130/80 mm Hg for diabetic participants.
Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 12 Months
时间窗: 12 months
Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<140/90 mm Hg for non-diabetic participants, and SBP/DBP \<130/80 mm Hg for diabetic participants.
Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 6 Months
时间窗: 6 months
Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) \<140/90 mm Hg for non-diabetic participants, and SBP/DBP \<130/80 mm Hg for diabetic participants.
次要结局
- Change From Baseline in Microalbuminuria (MAU) at 6 Months(Baseline, 6 Months)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 6 Months(Baseline, 6 Months)
- Change From Baseline in Microalbuminuria (MAU) at 3 Months(Baseline, 3 Months)
- Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy(Day 0 (Baseline), 12 months)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 12 Months(Baseline,12 Months)
- Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 6 Months of Therapy(6 Months)
- Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy(Day 0 (Baseline), 12 months)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 3 Months(Baseline, 3 Months)
- Change From Baseline in Microalbuminuria (MAU) at 12 Months(Baseline, 12 months)
- Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 3 Months of Therapy(3 Months)
- Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 12 Months of Therapy(12 Months)
