New heart failure drug trial aims to ease breathing and save lives
NCT ID NCT07262723
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether levosimendan, a drug that strengthens heart contractions without increasing oxygen demand, can help people hospitalized with acute decompensated heart failure. About 332 adults will receive either levosimendan plus standard care or standard care alone. Researchers will track symptom improvement, side effects, and survival over 90 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Levosimendan
- What this could lead to
- If it works, this could provide a new treatment option for acute heart failure, improving symptoms and reducing hospital stays.
- What could go wrong
- This is a Phase 2/3 trial, so results are not yet proven. The drug may not show significant benefit over standard care, and side effects are possible.
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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 332 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Adult patients (age \>18 years) * Both male and female sex * Having left ventricular dysfunction, evidenced by a left ventricular ejection fraction \<40% within the prior 12 months * Hospitalized for the treatment of ADHF * Remained dyspneic at rest despite treatment with intravenous diuretics (NYHA class IV) * Patients might have received intravenous vasodilators and/or positive inotropic drugs (except amrinone and milrinone), but the infusion rates of these drugs must have remained constant for at least 2 h before entry into the study. Exclusion Criteria: * History of invasive cardiac procedure * Cardiac surgery during lifetime within 3 months prior to screening * Cardiac revascularization within 3 months prior to screening * Left ventricular assist device (LVAD) implantation within 3 months prior to screening * A cardioversion within 4 h prior to screening, or * Cardiac re-synchronization procedure within 30 days prior to screening) * Rhythm disorders (e.g. earlier Torsades de Pointes, increased heart rate) * Severe ventricular outflow obstruction * Angina within 6 h prior to screening * Hypotension (a systolic blood pressure \<90 mmHg) \[Can be included after resuscitation, when SBP will be \>90 mmHg by noradrenaline infusion\] * Uncorrected hypokalemia * CNS disease (e.g. stroke, TIA) * Respiratory (e.g. COPD exacerbation requiring systematic steroids or intubation) * Renal insufficiency (e.g. increased serum creatinine clearance rate \<15 mL/min) * Hepatic impairment (e.g. significant increase in liver enzymes, \>5x the upper limit of normal) * Decompensation from active infection eg, sepsis * Acute bleeding * Patient required blood transfusion or Severe anemia (hemoglobin \<8 g/l) * Serum potassium concentration \<3.5 or \>5.4 mmol/l * Use of amrinone and milrinone prior to screening * A history of hypersensitivity to levosimendan or any of the excipients * Intubated or otherwise unable to communicate * Pregnancy * Post partum cardiomyopathy * Previous participation in a clinical trial with any experimental treatment within the last 30 days
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Apollo Imperial Hospital & Max Hospital
Chittagong, 4202, Bangladesh
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Chattogram Maa-O-Shishu Hospital Medical College Hospital
Chittagong, 4100, Bangladesh
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Chittagong Medical College Hospital, Chattogram
Chittagong, 4000, Bangladesh
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Cox's Bazar Medical College
Cox’s Bāzār, 4700, Bangladesh
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National Institute of Cardiovascular Diseases
Dhaka, 1207, Bangladesh
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United Hospital Limited
Dhaka, 1212, Bangladesh
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a diabetes drug clear fluid from lungs in heart failure?
- Bedside blood test may reveal how well heart failure treatment works
- Can a newer heart failure drug protect kidneys better than an older one?
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- Could inflatable leg boots help heart failure patients?