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Levosimendan for Pulmonary Hypertension with Heart Failure (LEVEL Trial)

Phase 3
Recruiting
Research Sponsored by Tenax Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics
NYHA Class II or III or ambulatory NYHA class IV symptoms.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Pivotal Trial

Summary

This trial is going to compare the effectiveness of a medication called TNX-103 (levosimendan) with a placebo in people who have a condition called PH-HFpEF. They

Who is the study for?
This trial is for adults aged 18-85 with WHO Group 2 PH-HFpEF, a heart condition where the left side of the heart doesn't pump well leading to high blood pressure in lungs. Participants need a specific range of walking ability and stable medication use. Pregnant or breastfeeding women can't join, and those who can have children must use effective birth control.
What is being tested?
The study tests TNX-103 (levosimendan) against a placebo in patients with PH-HFpEF by measuring changes in their walking distance over six minutes from Day 1 to Week 12. The goal is to see if TNX-103 improves exercise capacity compared to no active treatment.
What are the potential side effects?
While not specified here, levosimendan may cause headaches, low blood pressure, irregular heartbeat or chest pain based on its action on the heart and blood vessels. Side effects vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with a specific type of high blood pressure in the lungs due to heart failure.
Select...
I have moderate to severe heart symptoms but can still walk.
Select...
I can walk between 100 and 450 meters without stopping.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change NYHA functional class
Change in NT-proBNP
KCCQ

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: TNX-103Active Control1 Intervention
oral levosimendan
Group II: PlaceboPlacebo Group1 Intervention
Placebo

Find a Location

Who is running the clinical trial?

Northwestern UniversityOTHER
1,652 Previous Clinical Trials
961,363 Total Patients Enrolled
Tenax Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
989 Total Patients Enrolled
Medpace, Inc.Industry Sponsor
96 Previous Clinical Trials
29,725 Total Patients Enrolled
~101 spots leftby Mar 2027
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