Status:
COMPLETED
Diuretic Comparison Project
Lead Sponsor:
VA Office of Research and Development
Conditions:
Hypertension
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
The Diuretic Comparison Project aimed to evaluate whether chlorthalidone, as compared with hydrochlorothiazide, would reduce the risk of major nonfatal cardiovascular disease outcomes and non-cancer-r...
Detailed Description
Thiazide-type diuretics have been in use for more than 50 years and are considered as the first-line treatment for hypertension. Of the more than 1 million Veterans prescribed a thiazide-type diuretic...
Eligibility Criteria
Inclusion
- Inclusion criteria
- over age 65 years
- receiving hydrochlorothiazide from the VA pharmacy at a daily dose of 25 or 50 mg
- most recent SBP ≥120 mm Hg and no records of SBP \<120 mm Hg in the past 90 days
- Exclusion criteria:
- impaired decision-making capacity rendering the patient unable to provide informed consent (i.e., if there is any question during the nurse's EHR chart review that the individual does not have the ability to make an autonomous decision or the PCP declines permission to randomize)
- death expected within 6 months (inferred by PCP permission to randomize)
- blood potassium level \<3.1 or 3.5 (if taking digoxin) meq/L in the past 90 days
- blood sodium level \<130 meq/L in the past 90 days
- enrolled in Medicare Part C (This exclusion only applied if there might be insufficient EHR data available to the study team)
Exclusion
Key Trial Info
Start Date :
June 15 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2022
Estimated Enrollment :
20723 Patients enrolled
Trial Details
Trial ID
NCT02185417
Start Date
June 15 2016
End Date
December 29 2022
Last Update
May 22 2024
Active Locations (70)
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1
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States, 35233
2
Alaska VA Healthcare System, Anchorage, AK
Anchorage, Alaska, United States, 99504
3
Veterans Health Care System of the Ozarks, Fayetteville, AR
Fayetteville, Arkansas, United States, 72703
4
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
Little Rock, Arkansas, United States, 72205-5484