Table of contents

• Clinical trials overview
• Conditions being studied
• Trial phases and study designs
• Who can participate
• Main endpoints being measured
• Summary of the main trials

Clinical trials overview

These studies are testing Levosimendan in patients with serious illnesses that affect the heart, lungs, or brain.^[1] The trial goals include checking whether it improves heart function, helps patients recover faster, lowers the need for intensive support, and is safe to use in the studied groups.^[1][2]

Conditions being studied

Several trials focus on heart failure with depressed left ventricular ejection fraction, which means the heart’s main pumping chamber is not squeezing well enough.^[1] Other studies look at cardiogenic shock, a life-threatening state where the heart cannot pump enough blood to the body.^[2][7]

One Phase 2 study is in patients with aneurysmal subarachnoid hemorrhage, which is bleeding around the brain caused by a burst aneurysm, and it focuses on people at high risk of vasospasm.^[3] Another trial studies patients with failure to wean from invasive ventilation, meaning they cannot yet come off a breathing machine.^[4]

Additional trials include patients having surgery for functional moderate to severe tricuspid regurgitation with right ventricular dysfunction, patients with Takotsubo syndrome, patients in cardiac arrest, and patients with pulmonary hypertension with preserved left ventricular ejection fraction.^[5][6][8]

Trial phases and study designs

The trial set includes Phase 2 and Phase 3 studies, plus one study described as Low Intervention.^[1][2][3]

Phase 2 trials are smaller and usually help researchers learn whether a treatment shows promise.^{[3][6][7] Phase 3 trials are larger and are used to compare outcomes more strongly, often against placebo or standard treatment.[2][4][5][8]}

All of the listed studies are interventional, which means the researchers give a treatment and then measure what happens.^[1][2][3]

Who can participate

Each trial has its own entry rules, but the target groups are clearly described in the trial data.^{[1][2] The studies include patients with weak heart pumping, patients in intensive care, patients needing ECMO support, patients recovering from cardiac surgery, and patients with severe breathing or circulation problems.[4][5][7][8]}

Some studies have very small planned groups, such as 10, 30, 40, or 46 participants, while others are much larger and include 230, 250, 569, or 610 participants.^{[1][2][3][4][5][6][7][8]}

Main endpoints being measured

The trials measure different outcomes depending on the condition being studied.^{[1][2] In the heart failure study, the main outcomes are pulmonary blood pressure and cardiac output at 3 months, which show pressure in the lung blood vessels and how much blood the heart pumps each minute.[1]}

In cardiogenic shock, one study measures a combined result of death, need for ECLS (a machine that supports the heart and lungs), or dialysis at day 30.^[2] Another cardiogenic shock study measures change in left ventricular outflow tract velocity time integral, a Doppler ultrasound measure that helps estimate blood flow and pumping performance.^[7]

Other important outcomes include ventilator-free days by day 28, low cardiac output syndrome after surgery, in-hospital left ventricular ejection fraction recovery, survival at day 30 after cardiac arrest, vasospasm within 14 days after brain bleeding, and change in 6-minute walk distance after 26 weeks.^{[4][5][6][3][8]}

Some studies also measure safety outcomes such as adverse events, serious adverse events, vital signs, laboratory values, ECG changes, heart rate and rhythm, and other safety issues.^[8]

Summary of the main trials

The trial list shows active research in both critical care and heart disease settings.^{[1][2][4] Some trials compare Levosimendan with placebo, while others compare it with standard inotrope treatment or study it before surgery or during emergency care.[2][5][7][8]}

Across the studies, researchers are mainly trying to learn whether Levosimendan can improve recovery, reduce the need for intensive support, and help patients survive serious illness.^[2][4][6][8]