LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
Recruiting
Phase 3
Interventional Study
Pulmonary Hypertension Associated With HFpEF
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 85
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 540 (estimated)
- Sponsor
- Tenax Therapeutics, Inc. · Industry
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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.
Trial Locations
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Eligibility Criteria
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 qu…
Contacts