Hypertension Clinical Trial
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)
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].
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | March 30, 2022 |
Est. primary completion date | March 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Luoyang Oriental hospital | Beijing | Henan |
China | Center for chronic disease control | ShenZhen | ShenZhen |
China | Yankuang Hospital | Zoucheng | Shandong |
Lead Sponsor | Collaborator |
---|---|
China National Center for Cardiovascular Diseases |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Comparison of average change in BP from the first visit after randomization to 9-month between A-AC-ACD and A-AD-ADC, C-CA-CAD and C-CD-CDA, and D-DA-DAC or D-DC-DCA only in population 1, respectively. | Comparison of average change in BP from first visit after randomization to 9-month between protocol A-AC-ACD and A-AD-ADC, C-CA-CAD and C-CD-CDA, and D-DA-DAC or D-DC-DCA among population 1(SBP 140-159 mmHg, not currently taking any antihypertensive medications) . | Baseline; 1 year | |
Primary | 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. | Baseline; 1 year | |
Secondary | 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. | Baseline; 1 year | |
Secondary | 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. | Baseline; 1 year | |
Secondary | 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. | Baseline; 1 year | |
Secondary | Proportion of individuals intolerant to each of the four medications. | 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. | Baseline; 1 year | |
Secondary | Proportion of individuals who switched to usual care for any reason. | 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. | Baseline; 1 year |
Status | Clinical Trial | Phase | |
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