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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07465666
Acronym
REAL-HTN
Enrollment
500
Registered
2026-03-12
Start date
2026-09-15
Completion date
2027-08-15
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

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

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).

Interventions

None listed

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change From Baseline to Week 4 in Mean Sitting SBPBaseline to Week 4

Secondary

MeasureTime frameDescription
Change From Baseline to Week 4 in Mean Sitting DBPBaseline to Week 4
Change From Baseline to Week 4 in Mean Sitting Pulse PressureBaseline to Week 4
Proportion of Patients Achieving Target Office Blood Pressure at Weeks 4 and 12Weeks 4 and 12Target office blood pressure is defined as SBP \<130 mmHg and DBP \<80 mmHg.

Contacts

CONTACTNovartis Pharmaceuticals
novartis.email@novartis.com+41613241111
STUDY_DIRECTORNovartis Pharmaceuticals

Novartis Pharmaceuticals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026