Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Hypertension

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults capable of providing consent and who have uncontrolled hypertension Participants were either treatment-naïve or had uncontrolled hypertension on their existing antihypertensive medication. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypertensive Participants<br>Hypertensive diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction, who were naïve to trandolapril or on trandolapril within past 30 days. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 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. | 3 months | 
| Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 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. | 6 months | 
| Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 3 Months | Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg. | Baseline, 3 Months | 
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 6 Months | Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg. | Baseline, 6 Months | 
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 12 Months | Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg. | Baseline,12 Months | 
| Change From Baseline in Microalbuminuria (MAU) at 3 Months |  | Baseline, 3 Months | 
| Change From Baseline in Microalbuminuria (MAU) at 6 Months |  | Baseline, 6 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 | The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as controlled. | 3 Months | 
| Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 6 Months of Therapy | The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as controlled. | 6 Months | 
| Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 12 Months of Therapy | The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as controlled. | 12 Months | 
| Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy | Satisfaction with therapy at baseline (BL) and 12 months, using a 5-point Likert scale where participants responded to the question Are you satisfied with your current hypertension therapy?. The range of responses varied from 1 = not at all satisfied to 5 = extremely satisfied. Responses 2 through 4 were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively. | Day 0 (Baseline), 12 months | 
| Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy | Satisfaction with therapy at baseline (BL) versus 12 months, using a 5-point Likert scale where participants responded to the question Are you satisfied with your current hypertension therapy?. The range of responses varied from 1 = not at all satisfied to 5 = extremely satisfied. Responses 2 through 4 were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively. | Day 0 (Baseline), 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uncontrolled hypertension, trandolapril