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

NCT07465666 | Not Yet Recruiting

• 1 other identifier: CLCZ696AAE01
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hypertension

Keywords

Angiotensin Receptor-Neprilysin Inhibitor; Sacubitril/valsartan; High blood pressure

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 4 in Mean Sitting SBP

  Baseline to Week 4

Secondary Outcomes (3)

• 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

Study Arms (2)

ARNi Cohort

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

Monotherapy Cohort

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• Patients willing to provide written informed consent to participate in the study.

You may not qualify if:

• 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 m\^2).
• Pregnant or lactating women.
• Patients with serum potassium level ≥5.5 mmol/L at baseline.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 12, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 2, 2027
• Study Completion (Estimated): August 2, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share