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Heart drug may shield patients from Post-Surgery heart injury

NCT ID NCT05279651

Disease control Sponsor: Jagiellonian University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether ivabradine, a drug that slows heart rate, can prevent heart injury after noncardiac surgery. About 2,100 high-risk patients aged 45 and older will receive either ivabradine or a placebo before and after surgery. The goal is to see if the drug reduces heart damage within 30 days after surgery.

What this could mean

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

Active substance
Ivabradine
What this could lead to
If it works, this could offer a simple way to prevent heart injury after surgery, reducing hospital stays and complications.
What could go wrong
This is a large trial, but ivabradine may not reduce heart injury more than placebo. It also requires careful heart rate monitoring and may cause side effects like slow heart rate or vision issues.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

2,146 people

The number who actually took part.

Started

Jun 2022

Expected to finish

Jun 2026

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 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: 1. Undergoing noncardiac surgery 2. ≥45 years of age 3. Expected to require at least an overnight hospital admission after surgery 4. Provide written informed consent to participate in the PREVENT-MINS Trial, AND 5. Fulfill ≥1 of the following 5 criteria (A-E): A. History of coronary artery disease B. History of peripheral arterial disease C. History of stroke D. Undergoing major vascular surgery, OR E. Any 3 of 9 risk criteria: i. Undergoing major surgery ii. History of congestive heart failure iii. History of a transient ischaemic attack iv. Diabetes and currently taking an oral hypoglycemic agent or insulin v. Age ≥70 years vi. History of hypertension vii. Serum creatinine \>175 µmol/L (\>2.0 mg/dl) viii. History of smoking within 2 years of surgery ix. Undergoing emergent/urgent surgery Exclusion Criteria: 1. Conduction abnormalities: A. Non-sinus rhythm on ECG B. Sinoatrial or AV (2nd and 3d degree) blocks C. Sick sinus syndrome D. Long QT syndrome E. Pacemaker dependent 2. Transplanted heart (or on waiting list) 3. Use of a selected class I or III antiarrhythmic drug (quinidine, disopyramide, sotalol, ibutilide, amiodarone) or diltiazem/verapamil 4. Resting heart rate \<65 beats per minute on the day of surgery 5. Systolic blood pressure \<90 mmHg on the day of surgery 6. Acute decompensated heart failure, cardiogenic shock, acute myocarditis 7. Acute coronary syndrome within 2 months before surgery; 8. Stroke or transient cerebral ischaemia within 1 month before surgery 9. Known severe liver or kidney disease (MDRD creatinine clearance \<15 mL/min) 10. Inability to tolerate oral intake 11. Recent use of ivabradine (\<1 month) 12. Known allergy or hypersensitivity to ivabradine 13. Low-risk surgical procedure based on individual physician's judgment 14. Investigator considers the patient unreliable regarding requirement for study compliance 15. Women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding 16. Previously enrolled in the PREVENT-MINS study

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder myocardial ischemia

As listed by the trial registrant

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

Myocardial injury after noncardiac surgery (MINS) Myocardial ischemia

Contacts and locations

Locations

  • 5 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie

    Krakow, 30-901, Poland

  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

    Lodz, 92-213, Poland

  • Krakowski Szpital Specjalistyczny im. Jana Pawła II

    Krakow, 31-202, Poland

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 31-501, Poland

  • Samodzielny Publiczny Szpital Kliniczny 1 w Lublinie

    Lublin, 20-081, Poland

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego

    Szczecin, 72-252, Poland

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach

    Zabrze, 41-800, Poland

  • Samodzielny Publiczny Szpital Kliniczny Nr 2 Pomorskiego Uniwersytetu Medycznego

    Szczecin, 70-111, Poland

  • Specjalistyczny Szpital Wojewódzki w Ciechanowie

    Ciechanów, 06-400, Poland

  • Specjalistyczny Szpital im. Edwarda Szczeklika w Tarnowie

    Tarnów, 33-100, Poland

  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. z o.o.

    Krakow, 31-826, Poland

  • Szpital Specjalistyczny im. Stefana Żeromskiego w Krakowie

    Krakow, 31-913, Poland

  • Szpital Specjalistyczny św. Łukasza w Końskich

    Gmina Końskie, 26-200, Poland

  • Szpital Uniwersytecki im. Karola Marcinkowskiego w Zielonej Górze

    Zielona Góra, 65-001, Poland

  • Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza w Bydgoszczy

    Bydgoszcz, 85-094, Poland

  • Szpital Zakonu Bonifratrów św. Jana Grandego w Krakowie

    Krakow, 31-061, Poland

  • Szpital św. Rafała w Krakowie

    Krakow, 30-693, Poland

  • Uniwersytecki Szpital Kliniczny w Opolu

    Opole, 45-401, Poland

  • Uniwersytecki Szpital Kliniczny we Wrocławiu

    Wroclaw, 50-556, Poland

  • Uniwersyteckie Centrum Kliniczne Gdańskiego Uniwersytetu Medycznego

    Gdansk, 80-952, Poland

  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Centralny Szpital Kliniczny

    Warsaw, 02-097, Poland

  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciątka Jezus

    Warsaw, 02-005, Poland

  • Uniwersyteckie Centrum Kliniczne im. Prof. Kornela Gibińskiego Śląski Uniwersytet Medyczny

    Katowice, 40-752, Poland

  • Wojewódzki Szpital Specjalistyczny w Olsztynie

    Olsztyn, 10-561, Poland

  • Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON

    Warsaw, 04-141, Poland

  • ZZOZ Szpital Śląski w Cieszynie

    Cieszyn, 43-400, Poland

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