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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Effectiveness of Angiotensin Receptor-Neprilysin Inhibitor (ARNi) Therapy in Lowering Blood Pressure in Hypertensive Patients in the United Arab Emirates
- ClinicalTrials.gov ID
- NCT07465666
- Acronym / sponsor ID
- REAL-HTN / CLCZ696AAE01
- Conditions
- Hypertension
- Keywords
- Angiotensin Receptor-Neprilysin Inhibitor, Sacubitril/valsartan, High blood pressure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a clinical diagnosis of hypertension from hospitals across the United Arab Emirates.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change From Baseline to Week 4 in Mean Sitting SBP
Time frame: Baseline to Week 4
3 secondary outcomes
Change From Baseline to Week 4 in Mean Sitting DBP
Time frame: Baseline to Week 4
Change From Baseline to Week 4 in Mean Sitting Pulse Pressure
Time frame: Baseline to Week 4
Proportion of Patients Achieving Target Office Blood Pressure at Weeks 4 and 12
Time frame: Weeks 4 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Novartis Pharmaceuticals at 4 sites in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 4 in Mean Sitting SBP (time frame: Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.