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A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF); LEVEL: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

Recruiting

Levosimendan has not been approved by the FDA to treat people who have PH-HFpEF or approved to be taken by mouth (orally). In this study, we will measure the amount of levosimendan in blood at various times and evaluate the change in participants 6-Minute Walk Distance.

I'm interested

Male or Female
18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 85 years old
• diagnosis of pulmonary arterial hypertension
• on stable doses of heart medication for at least 30 days
• there are specific requirements for birth control for women and men
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
Exclusion Criteria:

• ability to walk is limited by anything other than symptoms (shortness of breath and fatigue) related to pulmonary hypertension
• other diagnosis related to heart function such as valve disease, cardiomyopathy, etc.
• current lung disease
• study staff will review additional inclusion & exclusion criteria

Drug: Placebo, Drug: TNX-103

Heart & Vascular, Rare Diseases

Clinics and Surgery Center (CSC), levosimendan, PH-HFpEF, pulmonary arterial hypertension, pulmonary vascular disease

Thenappan Thenappan - tthenapp@umn.edu
Thenappan Thenappan
PHASE3
STUDY00020954
See this study on ClinicalTrials.gov

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