Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT02817503
Status:
UNKNOWN
Last Update Posted:
2016-10-14
First Post:
2016-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of the Intensive Systolic Blood Pressure Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D020138', 'term': 'Hyperhomocysteinemia'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000592', 'term': 'Amino Acid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014804', 'term': 'Vitamin B Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006852', 'term': 'Hydrochlorothiazide'}], 'ancestors': [{'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-13', 'studyFirstSubmitDate': '2016-06-18', 'studyFirstSubmitQcDate': '2016-06-24', 'lastUpdatePostDateStruct': {'date': '2016-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Events related to the intensive blood pressure control, Hypotension, Syncope, Bradycardia or Arrhythmia, Hyperkalemia, Renal Failure', 'timeFrame': '6 months BP titration treatment period'}, {'measure': 'First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death hospitalization; Hospitalization', 'timeFrame': 'during the Randomization and Titration Treatment period', 'description': '6 months BP titration treatment period'}], 'primaryOutcomes': [{'measure': 'Achieved mean blood pressure levels in each of the treatment groups', 'timeFrame': '6 months BP titration treatment period'}], 'secondaryOutcomes': [{'measure': 'Carotid intima-media thickness (CIMT), Carotid plaques', 'timeFrame': '6 months BP titration treatment period'}, {'measure': 'Carotid-femoral pulse wave velocity, Brachial-ankle pulse wave velocity', 'timeFrame': '6 months BP titration treatment period'}, {'measure': 'Ankle brachial index', 'timeFrame': '6 months BP titration treatment period'}, {'measure': 'Urinary albumin-creatinine ratio', 'timeFrame': '6 months BP titration treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypertension', 'BP titration', 'intensive blood pressure control', 'primary prevention', 'China', 'H-type Hypertension'], 'conditions': ['Hypertension', 'Hyperhomocysteinemia']}, 'referencesModule': {'references': [{'pmid': '25771069', 'type': 'BACKGROUND', 'citation': 'Huo Y, Li J, Qin X, Huang Y, Wang X, Gottesman RF, Tang G, Wang B, Chen D, He M, Fu J, Cai Y, Shi X, Zhang Y, Cui Y, Sun N, Li X, Cheng X, Wang J, Yang X, Yang T, Xiao C, Zhao G, Dong Q, Zhu D, Wang X, Ge J, Zhao L, Hu D, Liu L, Hou FF; CSPPT Investigators. Efficacy of folic acid therapy in primary prevention of stroke among adults with hypertension in China: the CSPPT randomized clinical trial. JAMA. 2015 Apr 7;313(13):1325-35. doi: 10.1001/jama.2015.2274.'}, {'pmid': '32527283', 'type': 'DERIVED', 'citation': 'Huang X, Liu L, Song Y, Gao L, Zhao M, Bao H, Qin X, Wu Y, Wu Q, Bi C, Yue A, Fang C, Ma H, Cui Y, Tang G, Li P, Zhang Y, Li J, Wang B, Xu X, Wang H, Parati G, Spence JD, Wang X, Huo Y, Chen G, Cheng X; investigators of intensive BP control in China. Achieving blood pressure control targets in hypertensive patients of rural China - a pilot randomized trial. Trials. 2020 Jun 11;21(1):515. doi: 10.1186/s13063-020-04368-1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the current feasibility study is to test whether the blood pressure level of the study patients can be effectively and safely managed according to the intensive antihypertensive treatment protocol. Furthermore, the study will also examine the effect of intensive antihypertensive treatment on the intermediate cardiovascular diseases outcomes, including CIMT, carotid plaques, PWV ABI, and kidney function, etc.', 'detailedDescription': 'The China Stroke Primary Prevention Trial (CSPPT, NCT00794885) found that among hypertensive adults in China without a history of stroke or myocardial infarction, the combined use of enalapril and folic acid, compared with enalapril alone, significantly reduced the risk of first stroke. The mean systolic blood pressures were highly comparable between the two groups over the course of the trial (139.7mmHg and 139.8mmHg, respectively, in the enalapril-folic acid and the enalapril group). In the further analysis, lower systolic blood pressures seemed to be associated with greater reduction in cardiovascular outcomes in both of the treatment groups.\n\nHowever, due to inconsistencies in the results of the ACCORD and SPRINT trials, the appropriate targets for systolic blood pressure in effectively reducing cardiovascular events among hypertensive patients remain uncertain.\n\nThe proposed trial aims to test the hypothesis that among hypertensive patients aged 60 years or older, a lower systolic blood pressure goal will lead to greater reduction in stroke incidence.\n\nThe current feasibility study aims to test whether the blood pressure level of the study patients can be effectively and safely managed according to the intensive antihypertensive treatment protocol. Furthermore, the study will also examine the effect of intensive antihypertensive treatment on the intermediate cardiovascular diseases outcomes, including CIMT, carotid plaques, PWV ABI, and kidney function, etc.\n\nThe current feasibility study will enroll approximately 100 patients with H-type hypertension (hypertensive patients with hyperhomocysteinemia) aged 60 years or older, and without a history of major cardiovascular diseases.\n\nEligible patients will randomly assigned to one of three different systolic blood pressure (SBP) target groups (Group A, SBP: 140 - \\<150 mmHg; Group B, SBP: 130 - \\< 140 mmHg; and Group C, SBP \\< 130 mmHg).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Hypertensive patients aged 60 years or older.\n* SBP\\>= 150 mmHg but \\<180 mmHg, if currently (within the previous two weeks) not regularly treated with antihypertensive drugs.\n* If currently (at least 10 days on medications within the previous two weeks) regularly treated with antihypertensive drugs, blood pressure must meet the following criteria:\n\nSBP \\>= 140 mmHg but \\<170 mmHg, if regularly (no less than 10 days) taking 1 type of antihypertensive medication within the previous two weeks; SBP \\>= 130 mmHg but \\<160 mmHg, if regularly (no less than 10 days) taking 2 types of antihypertensive medications within the previous two weeks; SBP \\>= 130 mmHg but \\<150 mmHg, if regularly (no less than 10 days) taking 3 types of antihypertensive medication within the previous two weeks.\n\nFor patients taking a fixed-dose-combination (FDC), this treatment will be considered as two types of drugs if the dose of each component of the FDC is equal to higher than the routine therapeutic dose.\n\n* Blood homocysteine (Hcy)≥ 10μmol/L, or the patient is taking enalapril-folic acid;\n* Subject has read and signed a written, informed consent form.\n\nExclusion Criteria:\n\n* History of physician diagnosed stroke, myocardial infarction, heart failure, revascularization, or malignancy;\n* Clearly diagnosed secondary hypertension;\n* Undergoing regular renal dialysis or has been diagnosed with end-stage kidney disease;\n* Congenital or acquired organic heart disease;\n* Severe somatic disease preventing the participant from completing the trial, or based on the discretion of the investigators, the patient is incapable of participating;\n* Contraindicated or intolerable to ACEIs (including enalapril-folic acid) or a history of severe adverse effects to ACEIs;\n* Individuals with abnormal laboratory test results and/or clinical manifestations rendering them unsuitable to participate as judged by the investigators;\n* Any factor likely to limit adherence to interventions or jeopardize data collection, for example: dementia, severe mental disorders impeding expression or communication abilities, an inability to adhere the follow-up plan, plans to move in the near future, or, a history of unreliability in following a medication regimen or in keeping appointments;\n* Living with a family member (a spouse, for example) who has already participated in the study;\n* Unwilling to participate, unwilling or unable to change current therapeutic regimen;\n* Currently (or within one month) participating in another new drug trial.'}, 'identificationModule': {'nctId': 'NCT02817503', 'briefTitle': 'Feasibility Study of the Intensive Systolic Blood Pressure Control', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Nanchang University'}, 'officialTitle': 'Effects of Intensive Antihypertensive Therapies on the Risk of Stroke in Hypertensive Adults: A Prospective Randomized Open-Label Blinded-Endpoint Trial, a Feasibility Study', 'orgStudyIdInfo': {'id': '20151BDH80038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard BP control', 'description': "SBP within 140 - \\<150 mmHg. For all participants, enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target. For those who can't tolerate enalapril-folic acid well, other types of antihypertensive agents may be used as alternative choices.\n\nIf the target BP level is not achieved during the Titration or Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.", 'interventionNames': ['Drug: Standard BP control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moderate BP control', 'description': "SBP within 130 - \\<140 mmHg. For all participants, enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target. For those who can't tolerate enalapril-folic acid well, other types of antihypertensive agents may be used as alternative choices.\n\nIf the target BP level is not achieved during the Titration or Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.", 'interventionNames': ['Drug: Moderate BP control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intensive BP control', 'description': "SBP \\<130 mmHg. For all participants, enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target. For those who can't tolerate enalapril-folic acid well, other types of antihypertensive agents may be used as alternative choices.\n\nIf the target BP level is not achieved during the Titration or Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.", 'interventionNames': ['Drug: Intensive BP control']}], 'interventions': [{'name': 'Standard BP control', 'type': 'DRUG', 'otherNames': ['Enalapril-folic acid,amlodipine,hydrochlorothiazide'], 'description': 'Enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target.', 'armGroupLabels': ['Standard BP control']}, {'name': 'Moderate BP control', 'type': 'DRUG', 'otherNames': ['Enalapril-folic acid,amlodipine,hydrochlorothiazide'], 'description': 'Enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target.', 'armGroupLabels': ['Moderate BP control']}, {'name': 'Intensive BP control', 'type': 'DRUG', 'otherNames': ['Enalapril-folic acid,amlodipine,hydrochlorothiazide'], 'description': 'Enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target.', 'armGroupLabels': ['Intensive BP control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '264300', 'city': 'Yatou', 'state': 'Shandong', 'country': 'China', 'facility': "the People's Hospital of Rongcheng", 'geoPoint': {'lat': 37.1566, 'lon': 122.43762}}], 'overallOfficials': [{'name': 'Xiaoshu Cheng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Nanchang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University First Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiaoshu Cheng', 'investigatorAffiliation': 'Second Affiliated Hospital of Nanchang University'}}}}