Diuretic Comparison Project

  • STATUS
    Recruiting
  • End date
    Apr 15, 2023
  • participants needed
    13500
  • sponsor
    VA Office of Research and Development
Updated on 21 June 2021
Investigator
Alison L Klint
Primary Contact
Veterans Health Care System of the Ozarks, Fayetteville, AR (1.2 mi away) Contact
+67 other location
hypertension
stroke
systolic blood pressure
myocardial infarction
infarct
diuretics
thiazide
hydrochlorothiazide
chlorthalidone

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.

Description

Over 1 million Veterans are prescribed a thiazide-type diuretic each year; over 95% receive hydrochlorothiazide, and fewer than 2.5% receive chlorthalidone. Both medications are thiazide-type diuretics that have been used for more than 50 years and are considered first-line treatment for hypertension. Indirect evidence has been accumulating, however, that chlorthalidone may be more effective than hydrochlorothiazide at preventing cardiovascular events. This will be the first randomized head-to-head comparison of the effectiveness of these two drugs. The study plans to enroll 13,500 Veterans over 3 years and follow them on average for 3 years, resulting in a total study duration of 4.5 years. Patients currently prescribed hydrochlorothiazide will be randomized to either continue taking hydrochlorothiazide or to receive an equivalent dose of chlorthalidone. The unique 'point of care' or 'clinically integrated' study design will identify, enroll and follow subjects using the electronic medical record system and national VA and non-VA databases. The primary outcome is an event composite consisting of: stroke, myocardial infarction, non-cancer death, urgent revascularization, and hospitalization for acute congestive heart failure. All patient care, including the study drug, will continue to be managed by the primary care provider.

Primary Care Providers will also be included as participants in this research study. Adding providers as subjects will allow us to study the implementation of the point of care protocol design in addition to the original research question. The study team will collect data on diuretic management within the study and may contact providers by phone or email to learn reasons for declining a particular patient or discontinuing a new chlorthalidone order or an ongoing diuretic prescription.

If cardiovascular events are reduced by even a small amount by chlorthalidone, the public health effect will be considerable because of the large number of patients who take diuretics. A randomized trial, now feasible due to the investigators' efficient and inexpensive design, will provide evidence needed to better inform practice throughout the VA.

Details
Condition Vascular Diseases, Hypertension, Diabetes and Hypertension, High Blood Pressure (Hypertension), High Blood Pressure (Hypertension - Pediatric), Elevated Blood Pressure, high blood pressure, arterial hypertension
Treatment chlorthalidone, Hydrochlorothiazide (HCTZ)
Clinical Study IdentifierNCT02185417
SponsorVA Office of Research and Development
Last Modified on21 June 2021

Eligibility

Yes No Not Sure

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
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