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Can pushing blood pressure below 120 save hearts in diabetes?

NCT ID NCT03264352

Prevention Sponsor: XueQing Yu Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers test whether lowering systolic blood pressure to below 120 mm Hg prevents major cardiovascular events in adults with type 2 diabetes and high-normal blood pressure. The trial enrolls about 11,400 people aged 45 to 79. Participants receive either intensive treatment with Allisartan and amlodipine or standard care that starts medication only when blood pressure reaches 140/90 mm Hg.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Allisartan Isoproxil, an angiotensin receptor blocker, with amlodipine added as needed
What this could lead to
If intensive blood pressure lowering works, it could become a standard approach to prevent heart attacks and strokes in people with type 2 diabetes and high-normal blood pressure.
What could go wrong
Intensive treatment may cause side effects from blood pressure medications, such as dizziness or kidney problems, and the trial may not show a clear benefit over standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 11,414 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2018

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 79 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * irrespective of sex; * aged between 45 and 79 years; * with office-measured seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic; * diagnosed of type 2 diabetes mellitus (T2DM), currently on diabetic therapy; * informed consent provided and long-term follow-up possible Exclusion Criteria: * poor control of blood glucose, HbA1c \> 10.0% * administration of any antihypertensive medications within 1 month; * a history of hypoglycemic coma / seizure; * confirmed diagnosis of type 1 diabetes mellitus; * alanine-aminotransferase (ALT) or aspartate-aminotransferase (AST) over three times the upper limit of normal; * estimated glomerular filtration rate \< 45 ml/min/1.73m2; * a history of congestive heart failure with left ventricular ejection fraction \< 40%; * coronary artery disease requiring RAS blockers for secondary prevention; * acute on-set of stroke within 6 months prior to randomization; * a ratio of urinary albumin (in mg/L) to urinary creatinine (in g/L) (ACR) ≥ 300 mg/g; * known contraindications for the active study medications; * a history of psychological or mental disorder; * pregnancy or currently planning to have babies or lactation; * severe diseases such as severe heart diseases; * an expected residual life span less than 3 years; * a malignancy that clinical investigators consider as unsuitable to participate; * currently participating in another clinical trial.

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Conditions

The condition(s) this trial relates to.

hypertensive disorder Prehypertension type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adverse event Blood pressure Cardiovascular risk factor Diabetes mellitus type 2 Prehypertension

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Guangdong General Hospital

    RECRUITING

    Guangzhou, Guangdong, 501080, China

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