Diuretics In the Management of Essential Hypertension (DIME) Study

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of DIME is to evaluate the safety (i.e. new onset of diabetes and other metabolic adverse events), efficacy and cost-effectiveness of antihypertensive treatment with low dose diuretics. The researchers' hypothesis is that use of low dose thiazide diuretics is metabolically safe when used with other appropriate antihypertensives, effective in reduction of blood pressure and cheaper than treatment without diuretics. Therefore, this study is an equivalence trial.

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

Details

• Lead Sponsor: Kyoto University
• Collaborator: University of the Ryukyus
• Treatments: Diuretics; Sodium Chloride Symporter Inhibitors

Criteria

Inclusion Criteria:

• Aged 30 to 79 years

• With blood pressure being >150/>90 if they are not on any antihypertensive treatment

• With blood pressure being >140/>90 if they are already on antihypertensive drugs

• No history of type 2 diabetes

• No history of gout

Exclusion Criteria:

• With supine blood pressure being >200/>120

• Patients already on antihypertensive treatment if duration of treatment and drugs used are not identified

• Patients already on thiazide diuretics

• With type 2 diabetes

• With gout or hyperuricaemia (>8.0 mg/dl)

• With hypokalemia（<3.5mmol/L）

• With erectile dysfunction

• With renal dysfunction (s-creatinine > 2.0 mg/dL)

• With history of serious adverse reaction to thiazide diuretics

• With history of stroke or myocardial infarction within 6 months

• With history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within 6 months or in whom these interventions are planned

• With heart failure or left ventricular dysfunction (ejection fraction<40%)

• Patients who should be on thiazide diuretics

• With history of malignant tumor within 5 years

• Pregnant, possibility of pregnancy, or during breast feeding

• Patients who are deemed not eligible for this study for any reason