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. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility criteria
- Provide a personally signed and dated informed consent document prior to initiation of any study-related procedures that are not considered standard of care.
- Completed double-blind therapy in a PH-HFpEF clinical study sponsored by Tenax Therapeutics, Inc.
- May, in the opinion of the Investigator, benefit from continued levosimendan treatment.
- Female patients of childbearing potential must agree to use a highly effective method of contraception.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Discontinued treatment of blinded drug in the parent study for any reason other than study completion or Sponsor termination of the study.
- Pregnant or breastfeeding women.
- Local access to commercially available levosimendan.
- Inability to comply with planned study procedures.
- Patients planning with scheduled lung or heart transplant or cardiac surgery in the next 4 months.
- Dialysis developed since enrollment in parent study (either hemodialysis, peritoneal dialysis, continuous venovenous hemofiltration, or ultrafiltration).
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2.
- Liver dysfunction with Child Pugh Class B or C.
- Evidence of systemic bacterial, systemic fungal, or viral infection in last 2 weeks refractory to treatment.
- Weight > 150 kg.
- Systolic blood pressure (SBP) cannot be managed to ensure SBP > 100 mmHg at initiation of study drug.
- Heart rate ≥ 100 bpm with study drug, persistent for at least 10 minutes at screening.
- Hemoglobin < 80 g/L.
- Serum potassium < 3.0 mmol/L or > 5.5 mmol/L at baseline that is unresponsive to management .