Health TrialsbyHealthPanel

LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2

ConditionPulmonary Hypertension Associated With HFpEF
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorTenax Therapeutics, Inc.

About this trial

The purpose of this study is to assess the efficacy and safety of the study drug, levosimendan (given orally), compared to placebo in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) as measured by the change in 6-Minute Walk Distance.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men or women, ≥18 to 85 years of age

NYHA Class II or III or ambulatory NYHA Class IV symptoms

A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization (RHC)

A qualifying baseline RHC

Disqualifiers

A diagnosis of PH WHO Groups 1, 3, 4, or 5

Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy

Structural heart repair or replacement of the aortic valve or mitral valve (surgical or percutaneous) OR, planned valve intervention OR, the presence of significant valve disease

A diagnosis of pre-existing lung disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • TNX-103

    Drug

    Oral levosimendan

  • Placebo

    Drug

    Matching placebo (oral)

Treatment groups

540 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: TNX-103Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

6-Minute Walk Distance (6MWD)

Change in 6-minute walk distance

Time frame
26 weeks

Secondary outcomes

1

KCCQ (Kansas City Cardiomyopathy Questionnaire) score is a standardized measure that ranges from 0 to 100, where a higher score indicates better health.

Change in KCCQ Total Symptom Score

Time frame
26 weeks
2

Clinical Worsening Events

Number of Clinical Worsening Events

Time frame
26 weeks
3

Clinical Worsening Event

Time to first occurrence of a Clinical Worsening Event

Time frame
26 weeks
4

NYHA (New York Heart Association) classification assesses and categorizes a patient's physical ability and symptoms into four classes, the lower the classification, the least impact on physical activity.

Change in NYHA Functional Class

Time frame
26 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tenax Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now