An Observational Study to Describe the Effectiveness of Angiotensin Converting Enzyme Inhibitor and Calcium Channel Blocker Combination in the Management of Hypertensive Patients With Elevated Heart Rate and Type 2 Diabetes

Study Overview
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Brief Summary
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To describe the effectiveness of angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination on systolic blood pressure (SBP) lowering in hypertensive patients with elevated heart rate and type 2 diabetes

Official Title
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A Prospective Noninterventional, Observational Study to Describe the Effectiveness of Angiotensin Converting Enzyme Inhibitor and Non-dihydropyridine Calcium Channel Blocker Single Pill Combination in the Management of Hypertensive Patients With Elevated Heart Rate and Type 2 Diabetes Mellitus

Conditions
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Hypertension

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ≥ 18 years old Has been already diagnosed with hypertension Has been already diagnosed with type 2 diabetes mellitus Started using angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination within a maximum of 1 week before enrolment Heart rate ≥70 beat per minute Exclusion Criteria: Pregnant or breast feeding female Current need to use any other antihypertensive drug(s) in addition to angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination Having any contraindication for angiotensin-converting enzyme inhibitor or non-dihydropyridine calcium channel blocker; Has been treated by any anti-hypertensive treatment(s) before angiotensin-converting enzyme inhibitor and non-dihydropyridine calcium channel blocker single pill combination Is currently participating in another clinical or non-clinical study

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 patients<br>Hypertensive patients with elevated heart rate and type 2 diabetes mellitus | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in systolic blood pressure | mmHg | from baseline to week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in diastolic blood pressure (DBP) | mmHg | from baseline to week 8 | 
| Ratio of patients achieving blood pressure ≤ 140 and/or 90 mmHg |  | from baseline to week 8 | 
| Ratio of responder patients (reduction of SBP ≥20 mmHg and/or DBP ≥10 mmHg) |  | from baseline to week 8 | 
| Absolute change of heart rate | beat/min | from baseline to week 8 | 
| Correlation between absolute change in blood pressure and absolute change in heart rate |  | from baseline to week 8 | 
| The absolute change in PR interval on electrocardiography | ms. The PR interval indicates atrioventricular conduction time. | from baseline to week 8 | 
| The absolute change in HbA1c (if available) |  | from baseline to week 8 | 
| The absolute change in microalbuminuria (if available) | mg/mmol | from baseline to week 8 | 
| The ratio of patients experiencing an adverse event including the nature of the adverse event/severe adverse event |  | from baseline to week 8 | 
| The correlation between physician's office and home blood pressure measurements (Difference in medians) | mmHg | from baseline to week 8 | 
| Blood pressure variability (daily or hourly) in home blood pressure measurement |  | from baseline to week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Diabetes Mellitus, ACE Inhibitors, Calcium Channel Blockers