Back to resultsLearning Implementation of Guideline-based Decision Support System for Hypertension Treatment: Testing Alternative Antihypertensive Regimens Using ACE-Inhibitors, Calcium Channel Blockers and Diuretics (LIGHT-ACD)
Primary Purpose
Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Protocol initiate with A
Protocol initiate with C
Protocol initiate with D
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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
Sites / Locations
- Luoyang Oriental hospital
- Yankuang Hospital
- Center for chronic disease controlRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Protocol initiate with A
Protocol initiate with C
Protocol initiate with D
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Proportion of individuals with BP<140/90 mmHg at 9 month.
Proportion of individuals with BP<140/90 mmHg at 9 month among the individuals (population 1: SBP 140-159 mmHg, not currently taking any antihypertensive medications) who initiated with A, C, and D, among those (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.
Proportion of individuals with BP<160/100 mmHg at 9 month.
Proportion of individuals with BP<160/100 mmHg at 9 month among the individuals (population 1: SBP 140-159 mmHg, not currently taking any antihypertensive medications) who initiated with A, C, and D, among those (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 separately.
Proportion of individuals who received monotherapy, two-drug treatment, three-drug treatment, or referral at 9 month.
Proportion of individuals who received monotherapy (only in populations 1), two-drug treatment, three-drug treatment, or referral at 9 month among the individuals (population 1: SBP 140-159 mmHg, not currently taking any antihypertensive medications) who initiated with A, C, and D, among those (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.
Proportion of individuals intolerant to each of the four medications.
Proportion of individuals intolerant to each of the four medications among the individuals (population 1: SBP 140-159 mmHg, not currently taking any antihypertensive medications) who initiated with A, C, and D, among those (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.
Proportion of individuals who switched to usual care for any reason.
Proportion of individuals who switched to usual care for any reason among the individuals (population 1: SBP 140-159 mmHg, not currently taking any antihypertensive medications) who initiated with A, C, and D, among those (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.
Full Information
NCT ID
NCT03587103
First Posted
July 3, 2018
Last Updated
April 14, 2021
Sponsor
China National Center for Cardiovascular Diseases
1. Study Identification
Unique Protocol Identification Number
NCT03587103
Brief Title
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)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 21, 2019 (Actual)
Primary Completion Date
March 30, 2022 (Anticipated)
Study Completion Date
March 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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].
Detailed Description
The LIGHT-ACD Trial is conducted based on the LIGHT trial and aims to compare the efficacy of several guideline-based hypertensive medication regimens initiated with A, C and D for BP control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
5000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Protocol initiate with A
Arm Type
Experimental
Arm Description
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.
Arm Title
Protocol initiate with C
Arm Type
Experimental
Arm Description
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.
Arm Title
Protocol initiate with D
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Protocol initiate with A
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Protocol initiate with C
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Protocol initiate with D
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Baseline; 1 year
Secondary Outcome Measure Information:
Title
Proportion of individuals with BP<140/90 mmHg at 9 month.
Description
Proportion of individuals with BP<140/90 mmHg at 9 month among the individuals (population 1: SBP 140-159 mmHg, not currently taking any antihypertensive medications) who initiated with A, C, and D, among those (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.
Time Frame
Baseline; 1 year
Title
Proportion of individuals with BP<160/100 mmHg at 9 month.
Description
Proportion of individuals with BP<160/100 mmHg at 9 month among the individuals (population 1: SBP 140-159 mmHg, not currently taking any antihypertensive medications) who initiated with A, C, and D, among those (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 separately.
Time Frame
Baseline; 1 year
Title
Proportion of individuals who received monotherapy, two-drug treatment, three-drug treatment, or referral at 9 month.
Description
Proportion of individuals who received monotherapy (only in populations 1), two-drug treatment, three-drug treatment, or referral at 9 month among the individuals (population 1: SBP 140-159 mmHg, not currently taking any antihypertensive medications) who initiated with A, C, and D, among those (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.
Time Frame
Baseline; 1 year
Title
Proportion of individuals intolerant to each of the four medications.
Description
Proportion of individuals intolerant to each of the four medications among the individuals (population 1: SBP 140-159 mmHg, not currently taking any antihypertensive medications) who initiated with A, C, and D, among those (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.
Time Frame
Baseline; 1 year
Title
Proportion of individuals who switched to usual care for any reason.
Description
Proportion of individuals who switched to usual care for any reason among the individuals (population 1: SBP 140-159 mmHg, not currently taking any antihypertensive medications) who initiated with A, C, and D, among those (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.
Time Frame
Baseline; 1 year
Other Pre-specified Outcome Measures:
Title
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.
Description
Comparison of average change in BP from first visit after randomization to 9-month between protocol A-AC-ACD and A-AD-ADC, C-CA-CAD and C-CD-CDA, and D-DA-DAC or D-DC-DCA among population 1(SBP 140-159 mmHg, not currently taking any antihypertensive medications) .
Time Frame
Baseline; 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
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
Exclusion criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Zheng, MD, PhD
Phone
+86 60866813
Email
xin.zheng@fwoxford.org
First Name & Middle Initial & Last Name or Official Title & Degree
Harlan Krumholz, MD, SM
Phone
+86 60866813
Email
harlan.krumholz@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Zheng, MD, PhD
Organizational Affiliation
China National Center for Cardiovascular Disease
Official's Role
Principal Investigator
Facility Information:
Facility Name
Luoyang Oriental hospital
City
Beijing
State/Province
Henan
Country
China
Individual Site Status
Completed
Facility Name
Yankuang Hospital
City
Zoucheng
State/Province
Shandong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Center for chronic disease control
City
ShenZhen
State/Province
ShenZhen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Zheng
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35578345
Citation
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.
Results Reference
derived
Learn more about this trial
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)
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