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Calcium Sensitizer

Levosimendan for Pulmonary Hypertension and Heart Failure

Phase 2
Waitlist Available
Led By Stuart Rich, MD
Research Sponsored by Tenax Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of levosimendan in people with PH-HFpEF.

Who is the study for?
This trial is for patients with heart failure and pulmonary hypertension who've completed a prior PH-HFpEF study by Tenax Therapeutics. They must sign consent, possibly benefit from ongoing levosimendan treatment, agree to contraception if applicable, and follow the study plan. Excluded are those over 150kg, with certain heart rates or blood pressures, severe infections, advanced liver disease, planned transplants or surgeries, very low kidney function or hemoglobin levels, abnormal potassium levels unresponsive to treatment.Check my eligibility
What is being tested?
Patients in this trial will receive weekly doses of an injectable solution called Levosimendan. The aim is to assess its safety and effectiveness when used continuously over time in individuals with heart failure and high blood pressure in the lungs.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of Levosimendan may include headache, low blood pressure (which can cause dizziness), increased heart rate (tachycardia), irregular heartbeat (arrhythmias), and possible allergic reactions at the injection site.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Safety measured by number of adverse events (AEs )
Secondary outcome measures
6-minute walk test (6MWT)
Clinical Events: Death and hospitalizations
Patient global assessment
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: LevosimendanExperimental Treatment1 Intervention
A sterile 2.5 mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion

Find a Location

Who is running the clinical trial?

Tenax Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
1,099 Total Patients Enrolled
2 Trials studying Heart Failure
38 Patients Enrolled for Heart Failure
Stuart Rich, MDPrincipal InvestigatorTenax Therapeutics, Inc.

Media Library

Levosimendan (Calcium Sensitizer) Clinical Trial Eligibility Overview. Trial Name: NCT03624010 — Phase 2
Heart Failure Research Study Groups: Levosimendan
Heart Failure Clinical Trial 2023: Levosimendan Highlights & Side Effects. Trial Name: NCT03624010 — Phase 2
Levosimendan (Calcium Sensitizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03624010 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current capacity for enrollment in this research trial?

"This trial is not actively recruiting anymore, with its initial posting taking place on November 14th 2018 and the latest edit occurring April 29th 2021. If you're in search of other studies related to heart failure, there are currently 1,432 trials open for enrollment; furthermore, 11 trials requiring Levosimendan 2.5 mg/ml Injectable Solution remain active."

Answered by AI

What clinical conditions is Levosimendan 2.5 mg/ml Injectable Solution most commonly employed to alleviate?

"Levosimendan 2.5 mg/ml Injectable Solution is typically prescribed to treat acute decompensated heart failure (adhf), but can also be effective in managing symptoms associated with congestive heart failure, acute coryza, and other cardiac issues related to decompensation."

Answered by AI

Are there any openings available for participants in this clinical experiment?

"Data hosted on clinicaltrials.gov affirms that, while this medical trial was initially posted in November 2018 and last modified April 2021, it is not currently seeking patients for enrolment. Nevertheless, there are 1,443 other studies actively recruiting volunteers at the present moment."

Answered by AI

How many research centers are conducting this investigation?

"This study is taking place at numerous locations, including the University of Nebraska Medical Center in Omaha, Stanford Healthcare in Stanford and Mayo Clinic in Rochester. There are a total of 9 trial sites involved."

Answered by AI

What risks might be associated with the intake of Levosimendan 2.5 mg/ml Injectable Solution?

"Our company's assessment of levosimendan 2.5 mg/ml Injectable Solution on a scale from 1 to 3 is 2, as there exists limited research indicating its safety but no data demonstrating its efficacy."

Answered by AI

Has Levosimendan 2.5 mg/ml Injectable Solution been studied in prior clinical trials?

"Levosimendan 2.5 mg/ml Injectable Solution was initially observed in 2007 at the Children's Heart Center Linz and has since then been subject to 31 completed studies. Currently, 11 active trials are taking place with a large number being conducted from Omaha, Nebraska."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients
2018. "Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03624010.
~6 spots leftby Apr 2025
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