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Status unknownNCT03587103Updated Apr 15, 2021

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)

An interventional study of Protocol initiate with A and Protocol initiate with C in Hypertension, sponsored by China National Center for Cardiovascular Diseases. Status unknown at 3 sites in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-15.

Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
5,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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].

Read the 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.

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,690 studies on the registry are indexed under Hypertension; 966 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 90 across 4,996 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

China National Center for Cardiovascular Diseases is the lead sponsor of 256 studies on the registry; 134 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
5,000 participants (estimated)

Study arms

  • 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

  • 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

  • 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

Interventions

  • BehavioralProtocol 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.

  • BehavioralProtocol 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.

  • BehavioralProtocol 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.

06

What researchers measure

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.

    Time frame: Baseline; 1 year

Secondary outcomes

  1. 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.

    Time frame: Baseline; 1 year

  2. 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.

    Time frame: Baseline; 1 year

  3. 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.

    Time frame: Baseline; 1 year

  4. 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.

    Time frame: Baseline; 1 year

  5. 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.

    Time frame: 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.

    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

07

Study locations

1 of 3 sites recruiting
  • Luoyang Oriental hospital
    Beijing, Henan, China
    Completed
  • Yankuang Hospital
    Zoucheng, Shandong, China
    Active, not recruiting
  • Center for chronic disease control
    ShenZhen, ShenZhen, China
    • Xin Zheng · Contact
    Recruiting
08

References and documents

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. PubMed 35578345 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03587103
Lead sponsor
China National Center for Cardiovascular Diseases
Responsible party
Sponsor
First posted
Jul 16, 2018
Start date
Aug 21, 2019
Primary completion
Mar 30, 2022 (estimated)
Completion
Mar 30, 2022 (estimated)
Last update
Apr 15, 2021

Study contacts

Xin Zheng, MD, PhD
Contact
xin.zheng@fwoxford.org
+86 60866813
Harlan Krumholz, MD, SM
Contact
harlan.krumholz@yale.edu
+86 60866813
Xin Zheng, MD, PhD
principal investigator · China National Center for Cardiovascular Disease

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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