Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
Study NCT ID:
NCT07465666
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Real-world Study of the Effectiveness of Angiotensin Receptor-Neprilysin Inhibitor Therapy in Hypertensive Patients in the United Arab Emirates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-04-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-03-06', 'studyFirstSubmitQcDate': '2026-03-06', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 4 in Mean Sitting SBP', 'timeFrame': 'Baseline to Week 4'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 4 in Mean Sitting DBP', 'timeFrame': 'Baseline to Week 4'}, {'measure': 'Change From Baseline to Week 4 in Mean Sitting Pulse Pressure', 'timeFrame': 'Baseline to Week 4'}, {'measure': 'Proportion of Patients Achieving Target Office Blood Pressure at Week 4, 8, and 12', 'timeFrame': 'Week 4, 8, and 12', 'description': 'Target office blood pressure is defined as SBP \\<130 mmHg and DBP \\<80 mmHg.'}]}, 'conditionsModule': {'keywords': ['Angiotensin Receptor-Neprilysin Inhibitor', 'Sacubitril/valsartan', 'High blood pressure'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the real-world effectiveness of ARNi (sacubitril/valsartan) therapy and standard antihypertensive monotherapy in reducing blood pressure in hypertensive patients residing in the United Arab Emirates. Standard antihypertensive monotherapies will include angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), and calcium channel blockers (CCBs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with a clinical diagnosis of hypertension from hospitals across the United Arab Emirates.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Adult male or female patients (≥18 years).\n2. Patients with physician-diagnosed hypertension (as defined by the American Heart Association/American College of Cardiology international guidelines).\n3. 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.\n\n Note: Patients who transition from one monotherapy to another during the study are not eligible for inclusion.\n4. Patients willing to provide written informed consent to participate in the study.\n\nExclusion criteria:\n\n1. Patients with malignant or severe hypertension (systolic blood pressure \\[SBP\\] ≥180 mmHg, diastolic blood pressure \\[DBP\\] ≥110 mmHg) at baseline.\n2. Patients with secondary causes of hypertension, as determined by the treating physician.\n3. Patients with a history of, or at risk of developing, angioedema.\n4. Patients with evidence of severe renal impairment (e.g., estimated glomerular filtration rate \\[eGFR\\] \\<30 mL/min/1.73 m\\^2).\n5. Pregnant or lactating women.\n6. Patients with serum potassium level ≥5.5 mmol/L at baseline.'}, 'identificationModule': {'nctId': 'NCT07465666', 'acronym': 'REAL-HTN', 'briefTitle': 'A Real-world Study of the Effectiveness of Angiotensin Receptor-Neprilysin Inhibitor Therapy in Hypertensive Patients in the United Arab Emirates', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Real-world Effectiveness of Angiotensin Receptor-Neprilysin Inhibitor (ARNi) Therapy in Lowering Blood Pressure in Hypertensive Patients in the United Arab Emirates', 'orgStudyIdInfo': {'id': 'CLCZ696AAE01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ARNi Cohort', 'description': 'Patients with a clinical diagnosis of hypertension who initiate or switch to ARNi (sacubitril/valsartan) treatment.'}, {'label': 'Monotherapy Cohort', 'description': 'Patients with a clinical diagnosis of hypertension who initiate standard antihypertensive monotherapy including an ACE inhibitor, ARB, or CCB.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT', 'email': 'novartis.email@novartis.com', 'phone': '+41613241111'}, {'name': 'Novartis Pharmaceuticals', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}