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TNX-103 for Pulmonary Hypertension (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

LEVEL 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.Check my eligibility

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.See study design

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.

LEVEL Trial 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.

LEVEL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Six-minute walk distance from Baseline to Week 12

Secondary outcome measures

Change NYHA functional class

Change in NT-proBNP

Clinical Worsening Events

+1 more

LEVEL Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: TNX-103Active Control1 Intervention

levosimendan

Group II: PlaceboPlacebo Group1 Intervention

Placebo

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tenax Therapeutics, Inc.Lead Sponsor

6 Previous Clinical Trials

983 Total Patients Enrolled

Medpace, Inc.Industry Sponsor

94 Previous Clinical Trials

29,463 Total Patients Enrolled

Frequently Asked Questions

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

What is the aggregate count of individuals currently enrolled in this clinical investigation?

"Indeed, the details on clinicaltrials.gov indicate that this trial is actively seeking participants. The trial was initially posted on January 10th, 2024 and was most recently updated on January 17th, 2024. A total of 152 participants are needed for this study at a single location."

Answered by AI

Do I meet the necessary requirements to participate in this clinical investigation?

"This clinical trial aims to recruit a total of 152 individuals between the ages of 18 and 85 who have been diagnosed with World Health Organization (WHO) Group 2 PH-HFpEF, along with specific qualifying criteria. These include having an echocardiogram within the past month showing a left ventricular ejection fraction (LVEF) equal to or greater than 40%, achieving a minimum distance of at least 100 meters but no more than 450 meters during a qualifying six-minute walk test (6-MWT) conducted at screening, and meeting certain requirements for female participants regarding pregnancy testing and contraceptive measures."

Answered by AI

What is the level of patient safety associated with TNX-103?

"Based on the fact that this trial is in Phase 3 and has accumulated multiple rounds of safety data, our team at Power rates TNX-103's safety as a score of 3."

Answered by AI

Is the clinical trial inclusive of individuals who are younger than 85 years old?

"The eligibility criteria for this clinical trial specify that individuals aged between 18 and 85 can participate. It is worth noting that there are a total of 48 trials available specifically for participants under the age of 18, and an additional 646 trials catering to patients over the age of 65."

Answered by AI

Are participants being enrolled in this study at the present time?

"According to clinicaltrials.gov, this study is currently actively seeking participants. The trial was initially posted on January 10th, 2024 and underwent its most recent update on January 17th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

2024. "LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05983250.

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