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Heart failure drug levosimendan tested for long-term safety in 35 patients

NCT ID NCT03624010

Disease control Sponsor: Tenax Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at the safety of using levosimendan over a longer period in people who have both pulmonary hypertension and heart failure with preserved ejection fraction. 35 patients who had already been in a related study received the drug and were monitored for side effects. The main goal was to see how many adverse events occurred.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

35 people

The number who actually took part.

Started

Apr 2019

Finished

Apr 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Provide a personally signed and dated informed consent document prior to initiation of any study-related procedures that are not considered standard of care. 2. Completed double-blind therapy in a PH-HFpEF clinical study sponsored by Tenax Therapeutics, Inc. 3. May, in the opinion of the Investigator, benefit from continued levosimendan treatment. 4. Female patients of childbearing potential must agree to use a highly effective method of contraception. 5. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. Exclusion Criteria: 1. Discontinued treatment in the parent study for any reason other than study completion or Sponsor termination of the study. 2. Pregnant or breastfeeding women. 3. Local access to commercially available levosimendan 4. Inability to comply with planned study procedures 5. Patients with scheduled lung or heart transplant or cardiac surgery 6. Dialysis developed since enrollment in parent study (either hemodialysis, peritoneal dialysis, continuous venovenous hemofiltration, or ultrafiltration) 7. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 8. Liver dysfunction with Child Pugh Class B or C (see Attachment 2) 9. Evidence of systemic bacterial, systemic fungal, or viral infection refractory to treatment 10. Weight \>150kg 11. Systolic blood pressure (SBP) cannot be managed to ensure SBP \>100 mmHg at initiation of study drug 12. Heart rate \>100 bpm with study drug, persistent for at least 10 minutes at screening. 13. Hemoglobin \< 80 g/L 14. Serum potassium \< 3.0 mmol/L or \> 5.5 mmol/L at baseline that is unresponsive to management

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Conditions

The condition(s) this trial relates to.

cor pulmonale diastolic heart failure pulmonary hypertension

As listed by the trial registrant

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

Heart failure with normal ejection fraction Hypertension pulmonary secondary heart failure Right sided heart failure with normal ejection fraction

Contacts and locations

Locations

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Stanford Healthcare

    Stanford, California, 94305, United States

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213, United States

  • UW Health University Hospital

    Madison, Wisconsin, 53792, United States

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

More trials for these conditions

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