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Heart drug showdown: which protects the right ventricle better after valve surgery?

NCT ID NCT07416331

Disease control Sponsor: Helwan 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two drugs, levosimendan and dobutamine, in 52 adults undergoing heart valve replacement. The goal was to see which one better preserves right ventricular function after surgery. Patients were randomly assigned to receive one of the drugs, and their heart function was measured using echocardiograms at several time points.

What this could mean

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

Active substance
levosimendan and dobutamine
What this could lead to
If one drug proves better, it could become the preferred choice to protect heart function during valve surgery.
What could go wrong
This is a small, single-center study with only 52 patients, so results may not apply to everyone. The drugs also have known side effects like low blood pressure or heart rhythm 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.

Participants

52 people

The number who actually took part.

Started

Aug 2024

Finished

Aug 2025

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.

Who is studied

Adult patients scheduled for valve replacement surgery with PAH (an estimated right ventricular systolic pressure more than 50 mmHg, or mean PAP more than 40 mmHg, or systolic PAP exceeding 50% of systemic systolic pressure). Pregnant Patients or . Patients with severe renal dysfunction (GFR 15 to 29 ml/min per 1.73 m2 )or Severe hepatic or patients with Uncontrolled diabetes mellitus (HBA1C more than 8 )or patients needed inotropic support before surgery were excluded from the study.

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: * Age ≥18 years * Undergoing mitral and/or aortic valve replacement * PAH (an estimated right ventricular systolic pressure more than 50 mmHg, or mean PAP more than 40 mmHg, or systolic PAP exceeding 50% of systemic systolic pressure). Exclusion Criteria: * Potential pregnancy. * Refusal to participate. * Patients with severe renal dysfunction (GFR 15 to 29 ml/min per 1.73 m2 ) * Severe hepatic dysfunction.( Grade 4: AST/ALT \>20.0 x(upper limit normal ) * Prolonged QT interval. * Emergency surgery, * Requiring preoperative inotropes. * Uncontrolled diabetes mellitus (HBA1C more than 8 )

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension pulmonary hypertension rheumatic heart disease

As listed by the trial registrant

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

Pulmonary hypertension Right ventriculaire dysfunction

Contacts and locations

Locations

  • Helwan University

    Giza, 12566, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.