HypertensionREAL-HTNNCT07465666
A Real-world Study of the Effectiveness of Angiotensin Receptor-Neprilysin Inhibitor Therapy in Hypertensive Patients in the United Arab Emirates
An observational study of Hypertension, run by Novartis Pharmaceuticals at 4 sites in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypertension
- How many people
- 500 participants
- Where
- 4 sitesUnited Arab Emirates
- Study dates
- 15 Oct 2026to 31 Aug 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a clinical diagnosis of hypertension from hospitals across the United Arab Emirates.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
United Arab Emirates4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Abu Dhabi
- Recruiting
Novartis Investigative Site
Dubai
- Recruiting
Novartis Investigative Site
Fujairah
- Recruiting
Novartis Investigative Site
Ras al-Khaimah
About this study
Official title: 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).
- Conditions
- Hypertension
- Keywords
- Angiotensin Receptor-Neprilysin Inhibitor, Sacubitril/valsartan, High blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 4 in Mean Sitting SBP
Measured: Baseline to Week 4
Secondary outcomes (3)
Change From Baseline to Week 4 in Mean Sitting DBP
Measured: Baseline to Week 4
Change From Baseline to Week 4 in Mean Sitting Pulse Pressure
Measured: Baseline to Week 4
Proportion of Patients Achieving Target Office Blood Pressure at Weeks 4 and 12
Target office blood pressure is defined as SBP <130 mmHg and DBP <80 mmHg.
Measured: Weeks 4 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start15 Oct 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465666
- Sponsor's protocol ID
- CLCZ696AAE01
- Acronym
- REAL-HTN
- Status last verified
- Oct 2026
- First submitted
- 6 Mar 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Individual data sharing
- No