Learning Implementation of Guideline-based Decision Support System for Hypertension Treatment: Testing Alternative Antihypertensive Regimens Using ACE-Inhibitors, Calcium Channel Blockers and Diuretics (LIGHT-ACD)
NCT ID: NCT03587103
Last Updated: 2021-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
5000 participants
INTERVENTIONAL
2019-08-21
2022-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Protocol initiate with A
Eligible participants will be randomized to receive one of the protocols initiated with A, or the protocols initiated with two-drug combination therapy with full dose A.
Protocol initiate with A
The BP-lowering medication adjustment and titration will follow A-AC-ACD or A-AD-ADC for individuals randomized to A or two-drug combination therapy with full dose of A in their initial medication assignment.
Protocol initiate with C
Eligible participants will be randomized to receive one of the protocols initiated with C, or the protocols initiated with two-drug combination therapy with full dose C.
Protocol initiate with C
The BP-lowering medication adjustment and titration will follow C-CA-CAD or C-CD-CDA for individuals randomized to C or two-drug combination therapy with full dose of C in their initial medication assignment.
Protocol initiate with D
Eligible participants will be randomized to receive one of the protocols initiated with D, or the protocols initiated with two-drug combination therapy with full dose D.
Protocol initiate with D
The BP-lowering medication adjustment and titration will follow D-DA-DAC or D-DC-DCA for individuals randomized to D or two-drug combination therapy with full dose of D in their initial medication assignment.
Interventions
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Protocol initiate with A
The BP-lowering medication adjustment and titration will follow A-AC-ACD or A-AD-ADC for individuals randomized to A or two-drug combination therapy with full dose of A in their initial medication assignment.
Protocol initiate with C
The BP-lowering medication adjustment and titration will follow C-CA-CAD or C-CD-CDA for individuals randomized to C or two-drug combination therapy with full dose of C in their initial medication assignment.
Protocol initiate with D
The BP-lowering medication adjustment and titration will follow D-DA-DAC or D-DC-DCA for individuals randomized to D or two-drug combination therapy with full dose of D in their initial medication assignment.
Eligibility Criteria
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Inclusion Criteria
2. Local resident of the community/township who attend a PHC center with DSS treatment of hypertension
3. Established diagnosis of essential hypertension, with SBP≥140mmHg and \<180mmHg
4. Not currently taking any antihypertensive medication or taking only one antihypertensive medication which in not B
Exclusion Criteria
2. Physician-diagnosed or self-reported CKD, eGFR \<60 mL/min/1.73m2 (if serum creatinine available), or currently on dialysis
3. Physician-diagnosed diabetes mellitus
4. Physician-diagnosed heart failure
5. Physician-diagnosed secondary hypertension
6. Intolerance to any class of antihypertensive medications among A, C or D
7. Other serious medical illness such as malignant cancer, hepatic dysfunction, et al.
8. Currently at the acute phase of any diseases
9. Subject is pregnant or breast feeding, or planning to become pregnant or breast feeding during study period
10. Patients measured blood pressure at home and the average self-measured home blood pressure \<135/85mmHg
18 Years
ALL
Yes
Sponsors
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China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Xin Zheng, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
China National Center for Cardiovascular Disease
Locations
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Luoyang Oriental hospital
Beijing, Henan, China
Yankuang Hospital
Zoucheng, Shandong, China
Center for chronic disease control
Shenzhen, ShenZhen, China
Countries
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Central Contacts
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Facility Contacts
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Xin Zheng
Role: primary
References
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Song J, Wang X, Wang B, Gao Y, Liu J, Zhang H, Li X, Li J, Wang JG, Cai J, Herrin J, Armitage J, Krumholz HM, Zheng X; LIGHT Collaborative Group. Effectiveness of a clinical decision support system for hypertension management in primary care: study protocol for a pragmatic cluster-randomized controlled trial. Trials. 2022 May 16;23(1):412. doi: 10.1186/s13063-022-06374-x.
Other Identifiers
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2016-I2M-1-006-2
Identifier Type: -
Identifier Source: org_study_id
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