Phase 3 N=17,651 Randomized Treatment

Diuretic Comparison Project

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT02185417 ↗

Enrolled (actual)

17,651

Serious AEs

29.3%

Results posted

May 2024

Primary outcome: Primary: Time From Randomization to Composite Primary Outcome — 1.5; 1.5 Years — p=0.45

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Hydrochlorothiazide (HCTZ) (Drug); Chlorthalidone (CTD) (Drug)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Oct 2022

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	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02185417). 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.