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)

China National Center for Cardiovascular Diseases5,000 enrolled

Overview

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 \[D\].

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

5,000

Conditions

Hypertension

Interventions

Protocol initiate with ABEHAVIORAL

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.

Protocol initiate with CBEHAVIORAL

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.

Protocol initiate with DBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Luoyang Oriental hospital

Beijing, Henan, China

COMPLETED

Yankuang Hospital

Zoucheng, Shandong, China

ACTIVE_NOT_RECRUITING

Center for chronic disease control

Shenzhen, ShenZhen, China

RECRUITING

Outcomes

Primary Outcomes

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

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

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

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.

Central Contacts

Xin Zheng, MD, PhD

CONTACT

+86 60866813 xin.zheng@fwoxford.org

Harlan Krumholz, MD, SM

CONTACT

+86 60866813 harlan.krumholz@yale.edu

Data from ClinicalTrials.gov

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