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Clinical Trials/NCT03587103
NCT03587103
Unknown
Not Applicable

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 Diseases3 sites in 1 country5,000 target enrollmentAugust 21, 2019
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
China National Center for Cardiovascular Diseases
Enrollment
5000
Locations
3
Primary Endpoint
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)
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 21, 2019
End Date
March 30, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
China National Center for Cardiovascular Diseases
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

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)

Time Frame: Baseline; 1 year

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.

Secondary Outcomes

  • Proportion of individuals intolerant to each of the four medications.(Baseline; 1 year)
  • Proportion of individuals with BP<160/100 mmHg at 9 month.(Baseline; 1 year)
  • Proportion of individuals with BP<140/90 mmHg at 9 month.(Baseline; 1 year)
  • Proportion of individuals who received monotherapy, two-drug treatment, three-drug treatment, or referral at 9 month.(Baseline; 1 year)
  • Proportion of individuals who switched to usual care for any reason.(Baseline; 1 year)

Study Sites (3)

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