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 Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Protocol initiate with A
* Behavioral: Protocol initiate with C
* Behavioral: Protocol initiate with D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protocol initiate with A<br>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. | Behavioral: Protocol initiate with A<br>* 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.<br>|
| Experimental: Protocol initiate with C<br>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. | Behavioral: Protocol initiate with C<br>* 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.<br>|
| Experimental: Protocol initiate with D<br>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. | Behavioral: Protocol initiate with D<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline; 1 year | 
| 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. | Baseline; 1 year | 
| 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. | Baseline; 1 year | 
| 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. | Baseline; 1 year | 
| 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. | Baseline; 1 year |