Clinical trial NCT03587103: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2018-07-16
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Baseline; 1 year
Secondary outcomes:
measure: Proportion of individuals with BP<140/90 mmHg at 9 month.
timeFrame: Baseline; 1 year
measure: Proportion of individuals with BP<160/100 mmHg at 9 month.
timeFrame: Baseline; 1 year
measure: Proportion of individuals who received monotherapy, two-drug treatment, three-drug treatment, or referral at 9 month.
timeFrame: Baseline; 1 year
measure: Proportion of individuals intolerant to each of the four medications.
timeFrame: Baseline; 1 year
measure: Proportion of individuals who switched to usual care for any reason.
timeFrame: Baseline; 1 year
Other outcomes:
measure: 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.
timeFrame: Baseline; 1 year
Locations:
city: Beijing
country: China
facility: Luoyang Oriental hospital
state: Henan
city: Zoucheng
country: China
facility: Yankuang Hospital
state: Shandong
city: ShenZhen
country: China
facility: Center for chronic disease control
state: ShenZhen
Study officials:
affiliation: China National Center for Cardiovascular Disease
name: Xin Zheng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.