Diuretic Comparison Project

• Status: Recruiting
• Trial end date: 2023-04-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether chlorthalidone is more effective than hydrochlorothiazide at preventing cardiovascular outcomes in Veterans over age 65 with hypertension. Both medications are thiazide-type diuretics that have been used for more than 50 years and are considered first-line treatment for hypertension. Patients currently prescribed hydrochlorothiazide will be randomized to either continue taking hydrochlorothiazide or to receive chlorthalidone, and followed for major cardiovascular events, such as myocardial infarction (MI) and stroke. The study will use a new, efficient and less expensive study design termed 'point of care', in which study operations will be conducted centrally and patient data will be collected passively through the electronic medical record.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Chlorthalidone; Diuretics; Hydrochlorothiazide

Criteria

Inclusion Criteria:

Veterans who:

• Are over age 65 years

• Are receiving hydrochlorothiazide from the VA pharmacy at a daily dose of 25 or 50 mg

• Have a most recent systolic blood pressure (SBP) in CPRS greater than or equal to 120 mm Hg, with no SBP less than 120 mm Hg recorded in CPRS in the previous 90 days

Primary Care Providers will also be included as participants in this research study.

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 EMR 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)

• K<3.1 meq/L (or K<3.5 meq/L if on digoxin) in the past 90 days

• Na<130 meq/L in the past 90 days

• Known to be enrolled in Medicare Part C (assessed on consent phone call). This exclusion will only be employed if the investigators determine that sufficient information from Part C data cannot obtained.