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Completed

NCT Number: NCT01078584

Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site Reference ID/Investigator# 10283, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 3 Months

    Time frame: 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.

  2. Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 6 Months

    Time frame: 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.

  3. Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 12 Months

    Time frame: 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.

Secondary outcomes

  1. Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 3 Months

    Time frame: 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.

  2. Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 6 Months

    Time frame: 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.

  3. Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 12 Months

    Time frame: 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.

  4. Change From Baseline in Microalbuminuria (MAU) at 3 Months

    Time frame: Baseline, 3 Months

  5. Change From Baseline in Microalbuminuria (MAU) at 6 Months

    Time frame: Baseline, 6 Months

  6. Change From Baseline in Microalbuminuria (MAU) at 12 Months

    Time frame: Baseline, 12 months

  7. Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 3 Months of Therapy

    Time frame: 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."

  8. Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 6 Months of Therapy

    Time frame: 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."

  9. Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 12 Months of Therapy

    Time frame: 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."

  10. Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy

    Time frame: 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.

  11. Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy

    Time frame: 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.

Other outcomes

  1. Percentage of Participants Achieving 2008 CHEP Targets After 3 Months of Therapy

    Time frame: 3 Months

    Blood Pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."

  2. Percentage of Participants Achieving 2008 CHEP Targets After 6 Months of Therapy

    Time frame: 6 Months

    Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."

  3. Percentage of Participants Achieving 2008 CHEP Targets After 12 Months of Therapy

    Time frame: 12 Months

    Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."

  4. Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 3 Months of Therapy

    Time frame: 3 Months

    Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."

  5. Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 6 Months of Therapy

    Time frame: 6 Months

    Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."

  6. Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 12 Months of Therapy

    Time frame: 12 Months

    Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as "controlled."

  7. Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 3 Months

    Time frame: Day 0 (Baseline), 3 Months

  8. Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 6 Months

    Time frame: Day 0 (Baseline), 6 Months

  9. Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 12 Months

    Time frame: Day 0 (Baseline), 12 Months

  10. Mean Baseline Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts

    Time frame: Day 0 (Baseline)

  11. Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 3

    Time frame: Day 0 (Baseline), Month 3

  12. Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 6

    Time frame: Day 0 (Baseline), Month 6

  13. Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 12

    Time frame: Day 0 (Baseline), Month 12

  14. Number of Participants Compliant With Therapy After 3 Months

    Time frame: 3 Months

    Compliance after 3 months of treatment was derived using responses to the Visit 2 question "How many trandolapril (Mavik®) doses have been missed since the subject's last visit?" If the response was "zero", the participant was classified as "compliant." If the response was any value greater than zero, regardless of the number of missed doses, the participant was classified as "non-compliant."

  15. Number of Participants Compliant With Therapy After 6 Months

    Time frame: 6 Months

    Compliance after 6 months of treatment was derived using responses to the question "How many trandolapril (Mavik®) doses have been missed since the subject's last visit?" at both Visit 2 and Visit 3, as follows: If the response was "zero" at both the Visit 2 and Visit 3 assessments, participant was classified as "compliant" after 6 months of treatment; If the response was any value greater than zero at either of the Visit 2 or Visit 3 assessments, regardless of the number of missed doses, participant was classified as "non-compliant" after 6 months of treatment

  16. Number of Participants Compliant With Therapy After 12 Months

    Time frame: 12 Months

    Compliance after 12 months of treatment was derived using responses to the question "How many trandolapril doses have been missed since the subject's last visit?" at Visit 2, Visit 3 and Visit 4, as follows: if the response was "zero" at all of the Visits 2 through 4 assessments, the participant was classified as "compliant" after 12 months of treatment; if the response was any value greater than zero at any of the Visits 2 through 4 assessments, regardless of the number of missed doses, the participant was classified as "non-compliant" after 12 months of treatment.

  17. Number of Participants With Dose Changes at 3 Months

    Time frame: 3 Months

  18. Number of Participants With Dose Changes at 6 Months

    Time frame: 6 Months

  19. Number of Participants With Dose Changes at 12 Months

    Time frame: 12 Months

  20. Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 3 Months

    Time frame: 3 Months

    The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were "controlled" versus "uncontrolled" was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these "controlled" and "uncontrolled" participants who underwent or did not undergo a dose increase is presented.

  21. Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 6 Months

    Time frame: 6 Months

    The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were "controlled" versus "uncontrolled" was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these "controlled" and "uncontrolled" participants who underwent or did not undergo a dose increase is presented.

  22. Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 12 Months

    Time frame: 12 Months

    The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were "controlled" versus "uncontrolled" was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these "controlled" and "uncontrolled" participants who underwent or did not undergo a dose increase is presented.

  23. Number of Participants Adding Concomitant Cardiovascular Medications at 3 Months

    Time frame: 3 Months

    Presented by type of medication added.

  24. Number of Participants Adding Concomitant Cardiovascular Medications at 6 Months

    Time frame: 6 Months

    Presented by type of medication added.

  25. Number of Participants Adding Concomitant Cardiovascular Medications at 12 Months

    Time frame: 12 Months

    Presented by type of medication added.

  26. Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months

    Time frame: 3 Months

    Presented by type of medication discontinued.

  27. Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months

    Time frame: 6 Months

    Presented by type of medication discontinued.

  28. Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months

    Time frame: 12 Months

    Presented by type of medication discontinued.

  29. Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 3 Months

    Time frame: 3 Months

    Participants achieving the target of blood pressure <140/90 mm Hg were considered "controlled."

  30. Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 6 Months

    Time frame: 6 Months

    Participants achieving the target of blood pressure <140/90 mm Hg were considered "controlled."

  31. Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 12 Months

    Time frame: 12 Months

    Participants achieving the target of blood pressure <140/90 mm Hg were considered "controlled."

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Collaborators

  • McKesson Canada

Registry information

Official study title

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)

Acronym: in-MAU-tion

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 2, 2010
Registry last updated
Oct 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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