LEVEL-2: LEVosimendan To Improve Exercise Limitation In Patients With PH-HFpEF-2

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Men or women, ≥18 to 85 years of age
2. NYHA Class II or III or ambulatory NYHA Class IV symptoms
3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization (RHC)
4. A qualifying baseline RHC
5. A qualifying echocardiogram
6. A qualifying 6-MWD
7. A 48-hour ambulatory cardiac rhythm monitor during the Screening Period
8. Requirements related to child bearing potential, contraception, and egg/sperm donation)

Exclusion Criteria:

1. A diagnosis of PH WHO Groups 1, 3, 4, or 5
2. Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy
3. 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
4. A diagnosis of pre-existing lung disease
5. History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product
6. Major surgery within 60 days
7. Prior heart, lung, or heart-lung transplants or life expectancy of \<12 months
8. History of clinically significant other diseases that may limit or complicate participation in the study

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 03/16/2026. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Barry Borlaug, M.D.

Contact us for the latest status

More information

Publications

Publications are currently not available

Additional contact information

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