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)
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)
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.
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.
Inclusion Criteria:
Exclusion Criteria:
Whitby, British Columbia L1N 8M7, Canada
Conception Bay South, Newfoundland and Labrador A1W 3A6, Canada
Shubencadie, Nova Scotia B0N 2H0, Canada
Ameherstburg, Ontario N9V 0B4, Canada
Dolbeau-Mistassini, Ontario G8L 5J8, Canada
North York, Ontario M2J 2Z1, Canada
North York, Ontario M2N 7J5, Canada
North York, Ontario M2N 7J5, Canada
North York, Ontario M3B 2W7, Canada
North York, Ontario M3C 1T2, Canada
North York, Ontario M3C 1T2, Canada
North York, Ontario M3J 1N2, Canada
North York, Ontario M3N 2K1, Canada
North York, Ontario M3N 2Z9, Canada
North York, Ontario M9N 1X2, Canada
Saint Catherines, Ontario L2R 5K3, Canada
Saint Catherines, Ontario L2R 7P3, Canada
Surrey, Ontario V3W 2M9, Canada
Totonto, Ontario M4X 1G8, Canada
Clemont, Quebec G4A 1G3, Canada
Cote-St-Luc, Quebec H3W 1Z7, Canada
Grande-Allee, Quebec J7G 1W6, Canada
Saint Catherine, Quebec J5C 1A2, Canada
Shefford, Quebec J2M 1X4, Canada
St-Stanislas-De-Champlain, Quebec G0X 3E0, Canada
Ste Felicite, Quebec G0J 2K0, Canada
Ste Marie de Beauce, Quebec G6E 1N7, Canada
Ste-Marthe-sur-le-Lac, Quebec J0N 1P0, Canada