Newly diagnosed or uncontrolled hypertension Hypertension, Nebilet, Real-world patient study, Cardiovascular
Conditions
Interventions
Hypertensive patients with or without cardiovascular comorbidities who are newly prescribed or are already on Nebilet based treatment (no more than for 2 weeks at screening).
Treatment
Group 1
Sponsors
A. Menarini Asia-Pacific Holdings Pte Ltd
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adult patients who are 18 years of age or older with either newly diagnosed or uncontrolled hypertension (office SBP 140 or higher and/or DBP 90 mmHg or higher recorded at the time of screening) as per ESC/ESH guidelines 2018. 2. Hypertensive patients - with or without cardiovascular comorbidities (such as coronary artery disease, heart failure, peripheral artery disease, cerebrovascular disease, arrhythmias, and valvular heart disease) - who are newly prescribed or are already on Nebilet based treatment (no more than for 2 weeks at screening). 3. Hypertensive patients willing to provide consent to participate in the study. 4. Women of reproductive age who are willing to use adequate means of contraception.
Exclusion criteria
Exclusion criteria: 1. Patients with a recent cardiovascular event within less than 3 months. 2. Patients with heart failure based on New York Heart Association Functional Classification Class IV. 3. Patients with contraindications to Nebilet-based treatment as per the respective Summary of Product Characteristics which, in the treating judgment of physician, may jeopardize the subject by their participation in this study or may hamper their ability to perform and complete the procedures required in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean sitting diastolic blood pressure (DBP) from baseline to one year of treatment in hypertensive patients on Nebilet based treatment. one year of treatment systolic blood pressure | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in mean sitting Diastolic Blood Pressure (DBP) from baseline to one year of treatment in hypertensive patients on Nebilet based combination treatment. 3 years systolic and diastolic blood pressure,Change in mean sitting SBP and DBP from baseline to24 months and 36 months of treatment. 24 and 26 months systolic and diastolic blood pressure,Proportions of patients achieving target BP goal less than 140/90 mm Hg at visit 2 (12 months of treatment), visit 3 (24 months of treatment), and at the end of study (36 months of treatment). 12, 24, 36 months of treatment blood pressure,Proportions of patients achieving BP 130/80 mm Hg or lower at visit 2 (12 months of treatment), visit 3 and at the end of study 12, 24, 36 months of treatment blood pressure, The number of Major Adverse Cardiac Events (MACE) such as acute myocardial infarction, acute coronary syndrome, stroke, heart failure, all-cause death and cardiovascular death in patients 3 years blood pressure,Quality of life of patients at baseline, and at the end of one year, two years, and three years MINICHAL questionnaire,Patient reported outcome at baseline, and at the end of one year, two years, and three years short form of SF-36 questionnaire,Adherence to treatment every 3 months 8 Item Morisky Medication Adherence Scale,Comparison of Nebilet monotherapy and Nebilet based combination therapy in terms of proportion of patients achieving target BP goal less than 140/90 mm Hg 12, 24, 36 months of treatment Blood pressure | — |
Countries
Thailand
Contacts
Public ContactBibek Gyanwali
A. Menarini Asia-Pacific Holdings Pte Ltd
Outcome results
None listed