Levosimendan for Pulmonary Hypertension and Heart Failure
LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
- Age
- 18 – 85
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 540 (estimated)
- Sponsor
- Tenax Therapeutics, Inc. · Industry
This trial is looking for adults with pulmonary hypertension and heart failure. Participants will take either a medication called levosimendan or a placebo to see if it improves their walking distance.
You may be able to join if
- I am between 18 and 85 years old
- I have been diagnosed with pulmonary hypertension and heart failure
- I have symptoms classified as NYHA Class II, III, or ambulatory Class IV
- I have had a heart test (echocardiogram) that meets study requirements
- I have completed a 6-Minute Walk Distance test that meets study requirements
- I can wear a heart monitor for 48 hours during screening
You may not be able to join if
- I have been diagnosed with other types of pulmonary hypertension
- I have certain heart conditions such as hypertrophic or restrictive cardiomyopathy
- I have had heart valve surgery or plan to have valve surgery
- I have a history of serious lung disease
- I have had a severe allergic reaction to any ingredients in the study drug
- I have had major surgery in the last 60 days
- I have had a heart, lung, or heart-lung transplant
- I have other significant health issues that could affect my participation
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your EligibilityThe 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.
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