Diuretics In the Management of Essential Hypertension (DIME) Study

NCT ID: NCT00131846

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2013-11-30

Brief 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.

Detailed 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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

Diuretics use

Group Type: ACTIVE_COMPARATOR

Thiazide diuretics

Intervention Type: DRUG

Any dosage, frequency, and duration

2

No diuretics use

Group Type: ACTIVE_COMPARATOR

No diuretics

Intervention Type: DRUG

Any antihypertensive regimen other than diuretics

Interventions

Thiazide diuretics

Any dosage, frequency, and duration

Intervention Type: DRUG

No diuretics

Any antihypertensive regimen other than diuretics

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of the Ryukyus

OTHER

Sponsor Role: collaborator

Kyoto University

OTHER

Sponsor Role: lead

Responsible Party

Takeshi Morimoto

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shinichiro Ueda, MB, ChB, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology & Therapeutics, University of the Ryukyus

Locations

University of the Ryukyus

Nishihara, Okinawa, Japan

Countries

Japan

References

Ueda S, Morimoto T, Ando S, Takishita S, Kawano Y, Shimamoto K, Ogihara T, Saruta T; DIME Investigators. A randomised controlled trial for the evaluation of risk for type 2 diabetes in hypertensive patients receiving thiazide diuretics: Diuretics In the Management of Essential hypertension (DIME) study. BMJ Open. 2014 Jul 16;4(7):e004576. doi: 10.1136/bmjopen-2013-004576.

Reference Type: DERIVED

PMID: 25031188 (View on PubMed)

Other Identifiers

H15-choju-003

Identifier Type: -

Identifier Source: org_study_id