A Real-world Study of the Effectiveness of Angiotensin Receptor-Neprilysin Inhibitor Therapy in Hypertensive Patients in the United Arab Emirates

ConditionHypertension
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorNovartis Pharmaceuticals

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult male or female patients (≥18 years).

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).

Patients with documented office blood pressure ≥130/80 mmHg prior to initiating treatment (ARNi or monotherapy) or transitioning from monotherapy to ARNi.

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.

Disqualifiers

Patients with malignant or severe hypertension (systolic blood pressure [SBP] ≥180 mmHg, diastolic blood pressure [DBP] ≥110 mmHg) at baseline.

Patients with secondary causes of hypertension, as determined by the treating physician.

Patients with a history of, or at risk of developing, angioedema.

Patients with evidence of severe renal impairment (e.g., estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m²).

Trial population

Adult patients with a clinical diagnosis of hypertension from hospitals across the United Arab Emirates.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 2 trial groups
Group A: ARNi Cohort
Group B: Monotherapy Cohort

Trial outcomes

Primary outcomes

1

Change From Baseline to Week 4 in Mean Sitting SBP

Time frame
Baseline to Week 4

Secondary outcomes

1

Change From Baseline to Week 4 in Mean Sitting DBP

Time frame
Baseline to Week 4
2

Change From Baseline to Week 4 in Mean Sitting Pulse Pressure

Time frame
Baseline to Week 4
3

Proportion of Patients Achieving Target Office Blood Pressure at Weeks 4 and 12

Target office blood pressure is defined as SBP \<130 mmHg and DBP \<80 mmHg.

Time frame
Weeks 4 and 12

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: