Hypertension
Conditions
Keywords
Angiotensin Receptor-Neprilysin Inhibitor, Sacubitril/valsartan, High blood pressure
Brief summary
The aim of this study is to evaluate the real-world effectiveness of ARNi (sacubitril/valsartan) therapy and antihypertensive monotherapy in reducing blood pressure in hypertensive patients residing in the United Arab Emirates. Antihypertensive monotherapies will include angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), and calcium channel blockers (CCBs).
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
1. Adult male or female patients (≥18 years). 2. Patients with physician-diagnosed hypertension (as defined by international guidelines including the American Heart Association/American College of Cardiology \[AHA/ACC\] guidelines and/or the 2024 European Society of Cardiology \[ESC\] guidelines). 3. Patients with documented office blood pressure ≥130/80 mmHg prior to initiating treatment (ARNi or monotherapy) or transitioning from monotherapy to ARNi. 4. Patients who are either antihypertensive therapy naïve or currently receiving antihypertensive monotherapy (ACE inhibitor/ARB/CCB) with a physician-directed requirement to transition to ARNi. Note: Patients who transition from one monotherapy to another during the study are not eligible for inclusion. 5. Patients willing to provide written informed consent to participate in the study.
Exclusion criteria
1. Patients with malignant or severe hypertension (systolic blood pressure \[SBP\] ≥180 mmHg, diastolic blood pressure \[DBP\] ≥110 mmHg) at baseline. 2. Patients with secondary causes of hypertension, as determined by the treating physician. 3. Patients with a history of, or at risk of developing, angioedema. 4. Patients with evidence of severe renal impairment (e.g., estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m\^2). 5. Pregnant or lactating women. 6. Patients with serum potassium level ≥5.5 mmol/L at baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline to Week 4 in Mean Sitting SBP | Baseline to Week 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 4 in Mean Sitting DBP | Baseline to Week 4 | — |
| Change From Baseline to Week 4 in Mean Sitting Pulse Pressure | Baseline to Week 4 | — |
| Proportion of Patients Achieving Target Office Blood Pressure at Weeks 4 and 12 | Weeks 4 and 12 | Target office blood pressure is defined as SBP \<130 mmHg and DBP \<80 mmHg. |
Contacts
Novartis Pharmaceuticals