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New heart failure drug trial aims to ease breathing and save lives

NCT ID NCT07262723

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 332 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 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

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: * 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.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Apollo Imperial Hospital & Max Hospital

    Chittagong, 4202, Bangladesh

  • Chattogram Maa-O-Shishu Hospital Medical College Hospital

    Chittagong, 4100, Bangladesh

  • Chittagong Medical College Hospital, Chattogram

    Chittagong, 4000, Bangladesh

  • Cox's Bazar Medical College

    Cox’s Bāzār, 4700, Bangladesh

  • National Institute of Cardiovascular Diseases

    Dhaka, 1207, Bangladesh

  • United Hospital Limited

    Dhaka, 1212, Bangladesh

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