Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients

Launched by TENAX THERAPEUTICS, INC. · Aug 8, 2018

Keywords

ClinConnect Summary

This study will enroll PH-HFpEF patients that have completed a controlled levosimendan study. These patients will receive weekly open-label doses of levosimendan and be periodically evaluated for safety and effectiveness in extended use.

Gender

ALL

Eligibility criteria

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