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NCT Number: NCT07465666

A Real-world Study of the Effectiveness of Angiotensin Receptor-Neprilysin Inhibitor Therapy 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).

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Note: Patients who transition from one monotherapy to another during the study are not eligible for inclusion.

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

Exclusion criteria

  • 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.

Treatment and study plan

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

    Time frame: Weeks 4 and 12

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

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: REAL-HTN

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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