Phase 3
Completed N=17,651
Diuretic Comparison Project
Source: ClinicalTrials.gov NCT02185417 ↗Enrolled (actual)
17,651
Serious AEs
29.3%
Results posted
May 2024
Primary outcomePrimary: Time From Randomization to Composite Primary Outcome — 1.5; 1.5 Years — p=0.45
◆ Published Evidence
Highly cited
149citations · ~37 / year
Chlorthalidone vs. Hydrochlorothiazide for Hypertension-Cardiovascular Events.
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-related deaths in older patients with hypertension who were receiving hydrochlorothiazide at baseline. The investigators incorporated the pragmatic methods used by the Department of Veterans Affairs (VA) Healthcare System to provide a real-world assessment of the effectiveness of chlorthalidone as compared with hydrochlorothiazide in routine clinical care.
Linked Publications (5)
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Chlorthalidone vs. Hydrochlorothiazide for Hypertension-Cardiovascular Events.
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A Centralized EHR-Based Model for the Recruitment of Rural and Lower Socioeconomic Participants in Pragmatic Trials: A Secondary Analysis of the Diuretic Comparison Project.
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Chlorthalidone vs Hydrochlorothiazide and Kidney Outcomes in Patients With Hypertension: A Secondary Analysis of a Randomized Clinical Trial.
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Per-Protocol Analysis of Chlorthalidone Versus Hydrochlorothiazide for Cardiovascular Event Prevention-Diuretic Comparison Project.
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Provider experiences with and attitudes about an embedded pragmatic clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Randomization to Composite Primary Outcome |
1.5; 1.5 | 0.45 |
| PRIMARY Proportion of Participants Had a Composite Primary Outcome |
675; 702 | — |
| SECONDARY Proportion of Participants Had Nonfatal Myocardial Infarction |
140; 142 | — |
| SECONDARY Proportion of Participants Had Nonfatal Stroke |
83; 83 | — |
| SECONDARY Proportion of Participants Had Hospitalization for Heart Failure |
232; 242 | — |
| SECONDARY Proportion of Participants Had Unstable Angina Leading to Urgent Coronary Revascularization |
13; 20 | — |
| SECONDARY Proportion of Participants Deceased and Not Related to Cancer |
354; 359 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02185417) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.