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)

National Center for Cardiovascular Diseases

Status: Unknown

Conditions: Hypertension

Treatments: Behavioral: Protocol initiate with C; Behavioral: Protocol initiate with A; Behavioral: Protocol initiate with D

Study type: Interventional

Funder types: Other

Identifiers

NCT03587103

2016-I2M-1-006-2

Details and patient eligibility

About

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].

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5,000 participants in 3 patient groups

Protocol initiate with A

Experimental group

Description:

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.

Treatment:

Behavioral: Protocol initiate with A

Protocol initiate with C

Experimental group

Description:

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.

Treatment:

Behavioral: Protocol initiate with C

Protocol initiate with D

Experimental group

Description:

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.

Treatment:

Behavioral: Protocol initiate with D