Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-29 @ 8:35 PM
Study NCT ID:
NCT07067632
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2025-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Study the Mortality Outcome of Controlled Blood Pressure Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2025-07-06', 'studyFirstSubmitQcDate': '2025-07-06', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '100 year', 'description': 'All cause mortality by controlable hypertension treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertension', 'cardiovascular death'], 'conditions': ['Valid MeSH Conditions', 'Hypertension (HTN)']}, 'descriptionModule': {'briefSummary': 'Despite advances in antihypertensive therapy, some patients with well-controlled blood pressure still experience fatal outcomes. This paradox raises critical questions about the efficacy of blood pressure-targeted interventions and whether BP control alone ensures survival. This systematic review and meta-analysis aims to evaluate all-cause mortality and cardiovascular death among hypertensive patients who achieved BP targets in RCTs or open-label trials.\n\nTo determine whether achieving controlled blood pressure through intentional intervention (pharmacological or procedural) in RCTs or open-label studies reduces mortality (all-cause and cardiovascular) in hypertensive patients.', 'detailedDescription': 'Sensitivity Analyses Excluding high risk of bias studies\n\nExcluding short follow-up (\\<1 year)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults ≥18 years with diagnosed hypertension\n\nBlood pressure controlled at target values defined by the study (e.g., \\<140/90 mmHg or \\<130/80 mmHg)\n\nAny comorbidity allowed unless the study focuses on pregnancy or pediatric population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥18 years with diagnosed hypertension\n\nBlood pressure controlled at target values defined by the study (e.g., \\<140/90 mmHg or \\<130/80 mmHg)\n\nAny comorbidity allowed unless the study focuses on pregnancy or pediatric population\n\nExclusion Criteria:\n\n* Observational or retrospective studies\n\nPediatric or pregnant participants\n\nCase reports, editorials, or conference abstracts without full data\n\nStudies not reporting mortality outcomes separately for controlled BP'}, 'identificationModule': {'nctId': 'NCT07067632', 'acronym': 'HTN-Mort', 'briefTitle': 'To Study the Mortality Outcome of Controlled Blood Pressure Participants', 'organization': {'class': 'OTHER', 'fullName': 'DejthidaNathaphong'}, 'officialTitle': 'Mortality Outcome of Controlled Hypertension in Randomized Controlled or Open-label Study Intentionally Directed Intervention Effect Blood Pressure: A Systematic Review and Meta-Analysis', 'orgStudyIdInfo': {'id': 'DejthidaNathaphong'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Antihypertensive treatment', 'description': 'Participants assigned to interventions (pharmacological, device-based, or lifestyle) directed at lowering blood pressure or Antihypertensive agents, Blood pressure-lowering treatment, Antihypertensive therapy.', 'interventionNames': ['Drug: Antihypertensive treatment']}, {'label': 'Control/Comparator', 'description': 'Participants receiving placebo, standard of care, or no intervention'}], 'interventions': [{'name': 'Antihypertensive treatment', 'type': 'DRUG', 'otherNames': ['device-based blood pressure lowering', 'lifestyle modification'], 'description': 'Any intervention (pharmacological, device-based, lifestyle) intentionally directed at lowering BP\n\nControl groups receiving placebo, standard of care, or no intervention', 'armGroupLabels': ['Antihypertensive treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10110', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Nathaphong Dejthida, MD', 'role': 'CONTACT', 'email': 'bnnatto@gmail.com', 'phone': '+66819220662'}], 'facility': 'Nathaphong', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Nathaphong Dejthida', 'role': 'CONTACT', 'email': 'bnnatto@gmail.com', 'phone': '+66819220662'}], 'overallOfficials': [{'name': 'Nathaphong Dejthida, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DejthidaNathaphong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DejthidaNathaphong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}