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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)

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ClinicalTrials.gov Identifier: NCT03587103
Recruitment Status : Not yet recruiting
First Posted : July 16, 2018
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
China National Center for Cardiovascular Diseases

Tracking Information
First Submitted Date  ICMJE July 3, 2018
First Posted Date  ICMJE July 16, 2018
Last Update Posted Date July 25, 2019
Estimated Study Start Date  ICMJE August 15, 2019
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
Average change in BP from first visit after the decision support system is installed to 9-month. [ 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2018)
Average change in BP from baseline to 6-month after regimen randomization among the individuals who initiated with A, C, and D and among those who initiated with two-drug therapy with full dose A, full dose C or full dose D, respectively [ Time Frame: Baseline; 6 months ]
Change History Complete list of historical versions of study NCT03587103 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
  • The average change in BP from first visit to 9-month. [ Time Frame: Baseline; 1 year ]
    The average change in BP from first visit to 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 and among the individuals who followed protocols A-AC-ACD and A-AD-ADC, C-CA-CAD and C-CD-CDA, D-DA-DAC and D-DC-DCA, separately.
  • Proportion of individuals with BP<140/90 mmHg at 9 month. [ Time Frame: Baseline; 1 year ]
    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 and among the individuals who followed protocols A-AC-ACD and A-AD-ADC, C-CA-CAD and C-CD-CDA, D-DA-DAC and D-DC-DCA, separately.
  • Proportion of individuals with BP<160/100 mmHg at 9 month. [ Time Frame: Baseline; 1 year ]
    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 and among the individuals who followed protocols A-AC-ACD and A-AD-ADC, C-CA-CAD and C-CD-CDA, D-DA-DAC and D-DC-DCA, separately.
  • Proportion of individuals who received monotherapy, two-drug treatment, three-drug treatment, or referral at 9 month. [ Time Frame: Baseline; 1 year ]
    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 and among the individuals who followed protocols A-AC-ACD and A-AD-ADC, C-CA-CAD and C-CD-CDA, D-DA-DAC and D-DC-DCA, separately.
  • Proportion of individuals intolerant to each of the four medications. [ Time Frame: Baseline; 1 year ]
    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 and among the individuals who followed protocols A-AC-ACD and A-AD-ADC, C-CA-CAD and C-CD-CDA, D-DA-DAC and D-DC-DCA, separately.
  • Proportion of individuals who switched to usual care for any reason. [ Time Frame: Baseline; 1 year ]
    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 and among the individuals who followed protocols A-AC-ACD and A-AD-ADC, C-CA-CAD and C-CD-CDA, D-DA-DAC and D-DC-DCA, seperately.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2018)
  • Proportion of individuals with BP<140/90 mmHg [ Time Frame: Baseline; 6 months ]
  • Proportion of individuals with BP<160/100 mmHg [ Time Frame: Baseline; 6 months ]
  • Proportion of individuals who received monotherapy (only in populations 1), two-drug treatment, three-drug treatment, or referral [ Time Frame: Baseline; 6 months ]
  • Proportion of individuals who received prescriptions that were inconsistent with the decision support system recommendation [ Time Frame: Baseline; 6 months ]
  • Proportion of individuals who switched protocols because of intolerance to medication [ Time Frame: Baseline; 6 months ]
  • Proportion of individuals who switched to usual care for any reasons [ Time Frame: Baseline; 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Behavioral: Protocol 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.
  • Behavioral: Protocol 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.
  • Behavioral: Protocol 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.
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Behavioral: Protocol initiate with D
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2018)
5000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. SBP≥180mmHg and/or DBP≥110mmHg
  11. Patients measured blood pressure at home and the average self-measured home blood pressure <135/85mmHg
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Xin Zheng, MD, PhD +86 60866813 xin.zheng@fwoxford.org
Contact: Harlan Krumholz, MD, SM +86 60866813 harlan.krumholz@yale.edu
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03587103
Other Study ID Numbers  ICMJE 2016-I2M-1-006-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party China National Center for Cardiovascular Diseases
Study Sponsor  ICMJE China National Center for Cardiovascular Diseases
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xin Zheng, MD, PhD China National Center for Cardiovascular Disease
PRS Account China National Center for Cardiovascular Diseases
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP