LEVEL-2: LEVosimendan to Improve Exercise Limitation in PH-HFpEF-2
Research type
Research Study
Full title
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with Heart Failure with Preserved Left Ventricular Ejection Fraction
IRAS ID
1012772
Contact name
Akshata Ashokkumar
Contact email
Sponsor organisation
Tenax Therapeutics, Inc
Clinicaltrials.gov Identifier
Research summary
This study is being run by Tenax Therapeutics, Inc. The purpose of this study is to assess the efficacy and safety of the study medicine, 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. Levosimendan is approved in more than 50 countries to treat hospitalised patients with breathing difficulties associated with a type of serious heart failure called Acutely Decompensated Heart Failure (ADHF), and some doctors have noticed an improvement in participants with PH-HFpEF taking levosimendan in other research studies.
The study has two stages; in Stage 1, participants will receive either the study medicine (oral levosimendan) or placebo, and in Stage 2, all participants will receive the study medicine. During Stage 1, the participant may need to visit the study site approximately 7-10 times, and will have up to 9 phone calls. If they enter Stage 2 of the study, they may have up to 7 additional in person visits and up to 7 more phone calls. The length of study participation will depend on several factors and can vary from 34 to 112 weeks. About 540 people are expected to participate in this study globally.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
26/NW/0080
Date of REC Opinion
14 Apr 2026
REC opinion
Further Information Favourable Opinion