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

May 20, 2026 updated by: Novartis Pharmaceuticals

Real-world Effectiveness of Angiotensin Receptor-Neprilysin Inhibitor (ARNi) Therapy in Lowering Blood Pressure in Hypertensive Patients in the United Arab Emirates

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).

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline to Week 4 in Mean Sitting SBP
Time Frame: Baseline to Week 4
Baseline to Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 4 in Mean Sitting DBP
Time Frame: Baseline to Week 4
Baseline to Week 4
Change From Baseline to Week 4 in Mean Sitting Pulse Pressure
Time Frame: Baseline to Week 4
Baseline to Week 4
Proportion of Patients Achieving Target Office Blood Pressure at Weeks 4 and 12
Time Frame: Weeks 4 and 12
Target office blood pressure is defined as SBP <130 mmHg and DBP <80 mmHg.
Weeks 4 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLCZ696AAE01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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