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)

Not Applicable

• Conditions: Hypertension
• Interventions: Behavioral: Protocol initiate with A; Behavioral: Protocol initiate with D; Behavioral: Protocol initiate with C

• Registration Number: NCT03587103
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

Study Timeline

• Study First Submitted: 2018-07-03
• Study First Submitted QC: 2018-07-03
• Study First Posted: 2018-07-16
• Study Start: 2019-08-21
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-15
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protocol initiate with A	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 D	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 C	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.

Primary Outcome Measures

Name	Time	Method
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)	Baseline; 1 year	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

Name	Time	Method
Proportion of individuals intolerant to each of the four medications.	Baseline; 1 year	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 with BP<160/100 mmHg at 9 month.	Baseline; 1 year	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 with BP<140/90 mmHg at 9 month.	Baseline; 1 year	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 who received monotherapy, two-drug treatment, three-drug treatment, or referral at 9 month.	Baseline; 1 year	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 who switched to usual care for any reason.	Baseline; 1 year	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.

Trial Locations

Locations (3)

Center for chronic disease control; 🇨🇳 ShenZhen, ShenZhen, China

Luoyang Oriental hospital; 🇨🇳 Beijing, Henan, China

Yankuang Hospital; 🇨🇳 Zoucheng, Shandong, China