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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 : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
China National Center for Cardiovascular Diseases

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].

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Protocol initiate with A Behavioral: Protocol initiate with C Behavioral: Protocol initiate with D Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Age ≥18 years
  2. Local resident of the community/township who attend a PHC center with DSS treatment of hypertension at least once during the pre-randomization baseline period
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03587103


Contacts
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Contact: Xin Zheng, MD, PhD +86 60866813 xin.zheng@fwoxford.org
Contact: Harlan Krumholz, MD, SM +86 60866813 harlan.krumholz@yale.edu

Locations
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China, Henan
Luoyang Oriental hospital
Beijing, Henan, China
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Investigators
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Principal Investigator: Xin Zheng, MD, PhD China National Center for Cardiovascular Disease

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Responsible Party: China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT03587103     History of Changes
Other Study ID Numbers: 2016-I2M-1-006-2
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Calcium
Diuretics
Antihypertensive Agents
Angiotensin-Converting Enzyme Inhibitors
Calcium Channel Blockers
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Natriuretic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Membrane Transport Modulators