Could a blood pressure pill shield blood vessels from heart attacks?

NCT ID NCT05630612

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial tests whether sparsentan, a tablet that blocks a chemical called endothelin and lowers blood pressure, can improve blood vessel function and reduce stiffness in people with ANCA-associated vasculitis. Vasculitis is an autoimmune disease that damages blood vessels and raises the risk of heart attacks and strokes. The study will give sparsentan to one group and irbesartan, a standard blood pressure drug, to another for six weeks, then compare how well their blood vessels respond. The goal is to see if blocking endothelin for longer offers extra heart protection beyond just lowering blood pressure.

What this could mean

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

Active substance
sparsentan
What this could lead to
If it works, this could point toward a new way to lower heart attack and stroke risk in people with vasculitis, beyond just lowering blood pressure.
What could go wrong
This is a small, early-stage trial. The benefits seen after a few hours of treatment may not last over six weeks, and sparsentan may not prove better than standard blood pressure medication.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

32 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Sep 2027

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

18 years and older

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: * 18 years or older * A diagnosis of ANCA-associated vasculitis that has been in remission for ≥6 months. The diagnosis of AAV will have been made in accordance with the 2012 Revised International Chapel Hill Consensus Conference Nomenclature of Vasculitides criteria. Remission will be defined as a Birmingham Vasculitis Activity Score (BVAS) of 0 for at least 2 months prior to the screening visit whilst taking prednisolone at daily dose ≤7.5mg, in conjunction with the treating clinician's assessment of clinically silent disease. * eGFR ≥25ml/min/1.73m2 at screening. * Women of childbearing potential, beginning at menarche, must agree to the use of one highly reliable method of contraception (ie, a failure rate of \<1% per year) for at least 30 days prior to the first dose of the study medication (ie, for hormonal contraception) or according to manufacturer's recommendation (ie, for an intrauterine device) until 30 days after the last dose of the study medication, and must have a negative pregnancy test at screening. Women of childbearing potential are defined as those who are fertile, following menarche and until becoming postmenopausal, unless permanently sterile; permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as amenorrhea for more than 24 consecutive months without an alternative medical cause; women on hormone replacement therapy must have a documented plasma follicle-stimulating hormone level \>40 mIU/mL. Exclusion Criteria: * Age \<18 years * Active vasculitis * Liver disease * Untreated hypertension (defined as systolic blood pressure \>160 bpm and diastolic blood pressure \>100 bpm) * eGFR \<25ml/min/1.73m2 * Any organ transplant recipients * Haemodialysis/peritoneal dialysis patients * A requirement for any medications contraindicated whilst taking sparsentan * Congestive heart failure * Patients not medically fit to attend for study visits * Patients without mental capacity or willingness to provide informed consent * History of multiple and/or severe (clinical judgement as determined by the investigator) allergic reactions to drugs, including the study drug or food. * Patients who are pregnant or breast feeding, or those who plan to become pregnant during the study * Participation in another clinical trial for 28 days before or 90 days after the study period.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Centre for Cardiovascular Science, Queen's Medical Research Institute, 47 Little France Crescent

    Edinburgh, EH16 4TJ, United Kingdom

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