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)

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].

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Protocol initiate with A; Behavioral: Protocol initiate with C; Behavioral: Protocol initiate with 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 Type: Interventional
• Enrollment (Anticipated): 5000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xin Zheng, MD, PhD; Phone Number: +86 60866813; Email: xin.zheng@fwoxford.org
• Study Contact Backup: Name: Harlan Krumholz, MD, SM; Phone Number: +86 60866813; Email: harlan.krumholz@yale.edu

Study Locations

• China
  • Henan
    • Beijing, Henan, China
      • Completed
      • Luoyang Oriental hospital
  • Shandong
    • Zoucheng, Shandong, China
      • Active, not recruiting
      • Yankuang Hospital
  • ShenZhen
    • ShenZhen, ShenZhen, China
      • Recruiting
      • Center for chronic disease control
      • Contact: Xin Zheng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Age ≥18 years
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:

1. History of coronary heart disease (i.e., angina, MI, CABG, PCI, >50% stenosis of coronary artery, or positive stress test)
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: 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.
EXPERIMENTAL: 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.	Behavioral: 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.
EXPERIMENTAL: 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.	Behavioral: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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) .	Baseline; 1 year

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Xin Zheng, MD, PhD, China National Center for Cardiovascular Disease

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 21, 2019
• Primary Completion (ANTICIPATED): March 30, 2022
• Study Completion (ANTICIPATED): March 30, 2022

Study Registration Dates

• First Submitted: July 3, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (ACTUAL): July 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2016-I2M-1-006-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No