Trials / Active Not Recruiting
Active Not RecruitingNCT04040634
Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Patients With DIABETES Mellitus (OPTIMAL-DIABETES)
Large-Scale Randomized Clinical Trial Assessing Intensive Blood Pressure Control for Reduction of Major Cardiovascular Events in Patients With Diabetes Mellitus (OPTIMAL-DIABETES)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 9,476 (actual)
- Sponsor
- Hospital Israelita Albert Einstein · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
High blood pressure (BP) is a major public health concern, especially in low and middle income countries. High BP is a highly prevalent condition, and it is usually associated with diabetes mellitus. Both high BP and diabetes are risk factors for major cardiovascular events including cardiovascular death, acute myocardial infarction, stroke, unstable angina and heart failure. In addition, high BP is also related to cognitive decline. The OPTIMAL-DIABETES trial consists of a two-arm, multicenter, randomized clinical trial designed to test whether a lower systolic blood pressure (SBP) target will reduce the occurrence of major cardiovascular events in diabetic patients compared to the standard SBP target.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Intensive Control of Systolic Blood Pressure (SBP) | Participants in the Intensive arm have a goal of SBP \<120 mm Hg. The use of angiotensin converting enzyme (ACE) inhibitors/angiotension receptor blockers (ARB), thiazide-type diuretics, and calcium channel blockers (CCB) will be encouraged, preferably fixed-dose combinations of indapamide + perindopril arginine, perindopril arginine + amlodipine or indapamide + perindopril arginine + amlodipine |
| DRUG | Standard control of Systolic Blood Pressure (SBP) | The same medications used in the Intensive BP arm will be used for the Standard BP arm. |
Timeline
- Start date
- 2019-08-08
- Primary completion
- 2026-05-31
- Completion
- 2026-05-31
- First posted
- 2019-08-01
- Last updated
- 2026-03-27
Locations
32 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT04040634. Inclusion in this directory is not an endorsement.