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Diuretic Comparison Project

Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Hydrochlorothiazide (Drug); Chlorthalidone (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Department of Veterans Affairs

Official(s) and/or principal investigator(s):
Frank A. Lederle, MD, Study Chair, Affiliation: Minneapolis VA Health Care System, Minneapolis, MN

Overall contact:
Katherine Riley, Phone: (857) 364-2518, Email: Katherine.Riley@va.gov

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 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.

Clinical Details

Official title: CSP #597 - Diuretic Comparison Project

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time to major cardiovascular event

Secondary outcome:

Time to event for each component of the composite primary outcome and additional cardiovascular events

All Deaths

Urgent revascularization because of unstable angina

Hospitalization for acute congestive heart failure

Non-cancer death

The primary composite outcome substituting 'all deaths' for 'non-cancer deaths'

Possibly Vascular Deaths

The primary composite outcome substituting 'possibly vascular deaths' for 'non-cancer deaths'

Any revascularization of any artery

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

Eligibility

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

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 Exclusion Criteria:

- Impaired decision-making capacity rendering the patient unable to provide informed

consent (i. e., if there is any question during administration of informed consent 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 we determine that we cannot obtain sufficient information from Part C data.

Locations and Contacts

Katherine Riley, Phone: (857) 364-2518, Email: Katherine.Riley@va.gov

Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis, Minnesota 55417, United States; Not yet recruiting
Frank A Lederle, MD, Phone: 612-467-2683, Email: frank.lederle@va.gov
Frank A. Lederle, MD, Study Chair
Additional Information

Starting date: September 2015
Last updated: May 14, 2015

Page last updated: August 23, 2015

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