Levosimendan for Heart Failure

(LEVEL-2 Trial)

Recruiting at 75 trial locations

Overseen By Katelyn Jansson

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Tenax Therapeutics, Inc.

Disqualifiers: PH WHO Groups 1, 3, 4, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

540 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of an oral medication called levosimendan for individuals with a specific type of heart failure. It focuses on those with pulmonary hypertension (high blood pressure in the lungs) and heart failure, while their heart's pumping ability remains good. Researchers aim to determine if this drug can improve the distance someone can walk in six minutes, compared to those taking a placebo (a dummy pill). It suits individuals diagnosed with this specific heart condition who have undergone certain heart tests. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that levosimendan is likely to be safe for humans?

Research has shown that levosimendan is generally safe for people with advanced heart failure. Studies indicate it does not cause more unwanted side effects than other treatments. The most common side effects include low blood pressure, headaches, and low potassium levels. Monitoring these side effects is important, but they can usually be managed. Overall, levosimendan has been used safely for various heart conditions over the years, supporting its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Levosimendan is unique because it works by enhancing the heart's ability to pump blood without increasing oxygen demand, thanks to its calcium sensitization and potassium channel opening properties. Unlike standard treatments for heart failure, which often rely on beta-blockers, ACE inhibitors, or diuretics, levosimendan offers a dual mechanism that not only helps the heart muscle contract more effectively but also dilates blood vessels, improving circulation. Researchers are excited about levosimendan because it could lead to better outcomes for patients with heart failure, potentially improving their quality of life with fewer side effects.

What evidence suggests that levosimendan might be an effective treatment for heart failure?

Research shows that levosimendan, which participants in this trial may receive, can help people with heart failure. Studies have found that it improves heart pumping efficiency and lowers levels of brain natriuretic peptide, often elevated in heart failure patients. Levosimendan has been linked to a better quality of life and fewer hospital visits for those with sudden heart failure. Overall, it has been associated with less need for mechanical heart support and better survival rates. This suggests it could also benefit people with high blood pressure in the lungs and heart failure where the heart's pumping ability is preserved. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with a condition where the heart can't pump blood well (heart failure) and high blood pressure in the lungs. Participants must be able to walk on their own and have a specific type of heart failure where the left side of the heart isn't affected.

Inclusion Criteria

I can walk a specific distance without help.

Qualifying baseline RHC

Qualifying echocardiogram

Exclusion Criteria

I have been diagnosed with a specific type of pulmonary hypertension.

I have had or need surgery for heart valve repair or replacement.

History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an oral dose of levosimendan or placebo for 26 weeks

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may opt into continuation of treatment with levosimendan for 52 weeks

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Levosimendan

Trial Overview

The study is testing levosimendan, an oral medication, against a placebo to see if it helps patients with pulmonary hypertension and heart failure walk farther during a six-minute walking test.

How Is the Trial Designed?

Group I: TNX-103 Active Control 1 Intervention

Oral levosimendan

Group II: Placebo Placebo Group 1 Intervention

Matching placebo (oral)

Who Is Running the Clinical Trial?

Tenax Therapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

1,200+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11525400/

An Updated Meta-Analysis of Randomized Controlled Trials

Intermittent levosimendan significantly improved left ventricular ejection fraction, brain natriuretic peptide values, and all-cause mortality rate.

2.

reccardioclinics.org

reccardioclinics.org/en-impact-intermittent-levosimendan-treatment-on-avance-S2605153225001219

Impact of intermittent levosimendan treatment on quality ...

Intermittent outpatient levosimendan infusion was associated with significant and sustained QoL improvements in AHF, particularly during the ...

3.

cfrjournal.com

cfrjournal.com/articles/levosimendan-efficacy-and-safety-20-years-simdax-clinical-use?language_content_entity=en

Levosimendan Efficacy and Safety: 20 years of SIMDAX in ...

196 Levosimendan postponed or reduced the need for mechanical cardiac support in children with cardiomyopathy or who were undergoing cardiac ...

4.

mdpi.com

mdpi.com/2305-6320/12/4/23

Levosimendan in Decompensated Heart Failure with ...

The outcomes analyzed (O) were improvement in cardiac function, reduction in mortality, hospitalizations, and adverse events. The research question posed was: ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07262723

Levosimendan in Acute Decompensated Heart Failure

12 The results of this trial will provide critical insights into the potential benefits of levosimendan for treating ADHF, and could potentially ...

6.

internationaljournalofcardiology.com

internationaljournalofcardiology.com/article/S0167-5273(24)00513-8/abstract

Safety and efficacy of levosimendan in patients with ...

Levosimendan appears safe for CA patients needing inotropic support. The diuretic response and weight decrease during hospitalization were comparable.