Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients
- Conditions
- Hypertension
- Registration Number
- NCT01078584
- Lead Sponsor
- Abbott
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7993
- Adults capable of providing consent and who have uncontrolled hypertension
- Participants were either treatment-naïve or had uncontrolled hypertension on their existing antihypertensive medication.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 3 Months 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 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 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 6 Months Baseline, 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.
Change From Baseline in Microalbuminuria (MAU) at 3 Months Baseline, 3 Months Change From Baseline in Microalbuminuria (MAU) at 6 Months Baseline, 6 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 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.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 12 Months Baseline,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.
Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 6 Months of Therapy 6 Months 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."
Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy Day 0 (Baseline), 12 months 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.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 3 Months Baseline, 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.
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 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."
Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 12 Months of Therapy 12 Months 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."
Trial Locations
- Locations (568)
Site Reference ID/Investigator# 32207
🇨🇦Calgary, Alberta, Canada
Site Reference ID/Investigator# 10283
🇨🇦Calgary, Alberta, Canada
Site Reference ID/Investigator# 32168
🇨🇦Calgary, Alberta, Canada
Site Reference ID/Investigator# 32147
🇨🇦Calgary, Alberta, Canada
Site Reference ID/Investigator# 42438
🇨🇦Calgary, Alberta, Canada
Site Reference ID/Investigator# 32157
🇨🇦Calgary, Alberta, Canada
Site Reference ID/Investigator# 37940
🇨🇦Calgary, Alberta, Canada
Site Reference ID/Investigator# 32199
🇨🇦Calgary, Alberta, Canada
Site Reference ID/Investigator# 32144
🇨🇦Calgary, Alberta, Canada
Site Reference ID/Investigator# 32169
🇨🇦Calgary, Alberta, Canada
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