EBMtrialcentral- Comparing Initial Diuretic Therapies Using a Collaborative Network

• Status: Withdrawn
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

• Clinical equipoise exists with respect to the important question, "What is the best initial diuretic for the treatment of Hypertension"? A pragmatic comparative effectiveness research (CER) study comparing Chlorthalidone to Hydrochlorthiazide (HCTZ) could help inform decision making for this common problem.

• The investigators aim to harness both the power of bioinformatics (using web-based data-capture and electronic health records) and of online media (through collaboration) in order to facilitate such a CER in "usual-care" settings. This process may also provide a foundation for testing a wealth of important clinical questions which commonly arise in the delivery of contemporary healthcare and would otherwise be left unanswered.

• To this end the investigators are developing a website, EBMtrialcentral, where eligible physicians can go online and join their collaborative network. Physicians can then enroll eligible patients in this study. These will include under-served urban patients. Clinical information will be entered online (using a secure database housed at Johns Hopkins), patient consent will be obtained electronically and treatment recommendations will be randomly allocated to either 25mg daily of oral HCTZ or 12.5mg daily of oral Chlorthalidone. The investigators aim to increase to 50mg HCTZ and 25mg Chlorthalidone over 8 weeks and compare their effects on BP measured with a 24 hour monitor.

• The investigators' primary hypothesis is that non-blinded, random, parallel allocation of 12.5mg daily Chlorthalidone (titrated to 25mg at 4 weeks) will demonstrate a clinically meaningful ≥5mmHg improvement in BP control (as measured by change in BP from baseline using 24hr ABPM) compared to 25mg daily HCTZ (titrated to 50mg at 4 weeks) in newly hypertensive patients followed in a usual-care clinic setting over 8 weeks. They will also analyze differences in side-effects or safety (serum electrolytes) between these two medications.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Chlorthalidone; Diuretics; Hydrochlorothiazide

Criteria

Inclusion Criteria:

• Men and women are eligible if they have hypertension, are not receiving antihypertensive medications, and have average office BP values within the last 6 months ≥140/90 mmHg.

Exclusion Criteria:

• Patients with hypertensive urgency will be excluded (BP ≥180/120 mmHg). We also plan to exclude those with "compelling indications" for an Angiotensin Converting Enzyme (ACE) inhibitor or Beta-blocker therapy (per JNC 7). These include those with; a history of diabetes (prior HbA1c ≥6.5%, fasting glucose ≥126mg/dl, a history of insulin or oral hypoglycemic use, or microalbuminuria), myocardial infarction within the last 3 years, and a known LVEF <50%. Other safety exclusions will be; a history of chronic kidney disease (or a serum creatinine ≥1.8 mg/dL), known allergy to study medications, inability to provide consent, a history of significant non-compliance or missed appointments, a history of poorly-controlled gout and a history of falls or autonomic dysfunction and subjects aged <21years or ≥90yrs.