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)
1 other identifier
interventional
5,000
1 country
3
Brief Summary
This trial aims to compare the efficacy of several guideline-based hypertensive medication regimens initiated with Angiotensin Converting Enzyme Inhibitor/Angiotensin Receptor Blocker \[A\], Calcium Channel Blocker \[C\] and Diuretic \[D\].
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Aug 2019
Typical duration for not_applicable hypertension
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2018
CompletedFirst Posted
Study publicly available on registry
July 16, 2018
CompletedStudy Start
First participant enrolled
August 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2022
CompletedApril 15, 2021
April 1, 2021
2.6 years
July 3, 2018
April 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Average change in BP from first visit after the decision support system is installed to 9-month among the individuals who initiated with A, C, and D (population 1) and among those who initiated with two-drug therapy with AC, AD or CD (population 2)
Average change in BP from first visit after the decision support system is installed to 9-month among population 1 (SBP 140-159 mmHg, not currently taking any antihypertensive medications) who initiated with A, C, and D and among population 2 (SBP≥160 mmHg, taking 0-1 antihypertensive medications which is not B; or SBP 140-159mmHg, taking one antihypertensive medication which is not B) who initiated with two-drug therapy with AC, AD or CD, respectively.
Baseline; 1 year
Secondary Outcomes (5)
Proportion of individuals with BP<140/90 mmHg at 9 month.
Baseline; 1 year
Proportion of individuals with BP<160/100 mmHg at 9 month.
Baseline; 1 year
Proportion of individuals who received monotherapy, two-drug treatment, three-drug treatment, or referral at 9 month.
Baseline; 1 year
Proportion of individuals intolerant to each of the four medications.
Baseline; 1 year
Proportion of individuals who switched to usual care for any reason.
Baseline; 1 year
Other Outcomes (1)
Comparison of average change in BP from the first visit after randomization to 9-month between A-AC-ACD and A-AD-ADC, C-CA-CAD and C-CD-CDA, and D-DA-DAC or D-DC-DCA only in population 1, respectively.
Baseline; 1 year
Study Arms (3)
Protocol initiate with A
EXPERIMENTALEligible 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 C
EXPERIMENTALEligible 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 D
EXPERIMENTALEligible 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.
Interventions
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.
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.
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
You may qualify if:
- Age ≥18 years
- Local resident of the community/township who attend a PHC center with DSS treatment of hypertension
- Established diagnosis of essential hypertension, with SBP≥140mmHg and \<180mmHg
- Not currently taking any antihypertensive medication or taking only one antihypertensive medication which in not B
You may not qualify if:
- History of coronary heart disease (i.e., angina, MI, CABG, PCI, \>50% stenosis of coronary artery, or positive stress test)
- Physician-diagnosed or self-reported CKD, eGFR \<60 mL/min/1.73m2 (if serum creatinine available), or currently on dialysis
- Physician-diagnosed diabetes mellitus
- Physician-diagnosed heart failure
- Physician-diagnosed secondary hypertension
- Intolerance to any class of antihypertensive medications among A, C or D
- Other serious medical illness such as malignant cancer, hepatic dysfunction, et al.
- Currently at the acute phase of any diseases
- Subject is pregnant or breast feeding, or planning to become pregnant or breast feeding during study period
- Patients measured blood pressure at home and the average self-measured home blood pressure \<135/85mmHg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Luoyang Oriental hospital
Beijing, Henan, China
Yankuang Hospital
Zoucheng, Shandong, China
Center for chronic disease control
Shenzhen, ShenZhen, China
Related Publications (1)
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.
PMID: 35578345DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xin Zheng, MD, PhD
China National Center for Cardiovascular Disease
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2018
First Posted
July 16, 2018
Study Start
August 21, 2019
Primary Completion
March 30, 2022
Study Completion
March 30, 2022
Last Updated
April 15, 2021
Record last verified: 2021-04