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

Novartis

Status: Not yet enrolling

Conditions: Hypertension

Study type: Observational

Funder types: Industry

Identifiers

NCT07465666

CLCZ696AAE01

Details and patient eligibility

About

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).

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

ARNi Cohort

Description:

Patients with a clinical diagnosis of hypertension who initiate or switch to ARNi (sacubitril/valsartan) treatment.

Monotherapy Cohort

Description:

Patients with a clinical diagnosis of hypertension who initiate antihypertensive monotherapy including an ACE inhibitor, ARB, or CCB.