Diuretics In the Management of Essential Hypertension (DIME) Study

Hypertension Clinical Trial

Official title:

Effect of Low Dose Thiazide Diuretics on New Onset Type 2 Diabetes in Patients With Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00131846
• Other study ID #: H15-choju-003
• Status: Completed
• Phase: Phase 4
• Start date: April 2004
• Est. completion date: November 2013

Study information

• Verified date: June 2024
• Source: Kyoto University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

There has been substantial evidence from clinical trials to support the rationale of use of thiazide diuretics in patients with essential hypertension. Diuretics may be more effective in reduction of blood pressure in Japanese patients than Caucasian because of higher salt intake. Moreover, given a large number of hypertensive population here, diuretics may be the most cost-effective antihypertensive agent. Japanese physicians, however, tend to avoid diuretics even in elderly hypertensive patients because of much concern over metabolic adverse events including new onset diabetes, which is deemed to increase cardiovascular risk. Although it is unlikely that use of low dose (12.5 mg of HCTZ or less) diuretics is associated with metabolic adverse events when they are given with any other appropriate antihypertensive agents (e.g. Ca antagonist, ACE inhibitor, ARB, K sparing diuretics) other than β-blockers, the researchers have to confirm the safety of low dose diuretics in terms of new onset diabetes in Japanese, who are assumed to be "diabetes prone" based upon thrifty gene hypothesis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1130
• Est. completion date: November 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Thiazide diuretics
Any dosage, frequency, and duration
• No diuretics
Any antihypertensive regimen other than diuretics

Locations

Country	Name	City	State
Japan	University of the Ryukyus	Nishihara-cho	Okinawa

Sponsors (2)

Lead Sponsor	Collaborator
Kyoto University	University of the Ryukyus

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New onset type 2 diabetes (WHO criteria 1998)		five years
Secondary	Treatment resistant hypokalemia less than 3.5mEq/L		five years
Secondary	Ischemic and hemorrhagic Strokes excluding transient ischemic attacks and secondary causes		five years
Secondary	Myocardial infarction		five years
Secondary	Hospitalization due to heart failure		five years
Secondary	Arteriosclerosis obliterans (ASO)		five years
Secondary	Total death		five years
Secondary	Blood pressure		five years
Secondary	Lipid profile		five years
Secondary	HbA1c		five years
Secondary	Fasting blood sugar		five years
Secondary	Direct Cost		five years
Secondary	Gout (American College of Rheumatology 1997 criteria C)		five years